Philips Respironics V60 (REF 1053617)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13,525 adverse event reports that list this exact device (DI 00884838020054), received between Apr 22, 2015 and Sep 30, 2026 — classified as 30 deaths, 98 injuries, 13,397 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (1,887 reports).

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 28, 2022Class IOpen, Classified

   Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

   Z-0907-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 24, 2022Class IOpen, Classified

   A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).

   Z-0662-2022 · Root cause: Process control · Recall details · FDA record ↗

3. Jun 18, 2021Class IOpen, Classified

   It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

   Z-2073-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 13,525 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Shut Off

  Philips received a complaint by an Authorized Service Provider (ASP) on the V60 indicating a device malfunction as the device failed to turn on and off and needed to have the front bezel replaced. There was no patient involvement at the time the issue was discovered. No patient or user harm was reported.The ASP performed annual Preventive Maintenance (PM) and confirmed that the device could not be powered on and off as the ON/OFF switch was not working. No accessories, including third-party devices, were being used that may have contributed to the issue. The ASP performed a complete Performance Verification Test (PVT) per the manufacturer's specifications, checked the settings and event logs, and concluded that the issue originated from a faulty front bezel.Ultimately, the ASP replaced the front bezel and User Interface (UI) to Power Management (PM) cable, after which the issue was resolved. After installed the replacement parts, the ASP performed PVT, verified that the device passed all tests and calibrations and returned the device to service. The investigation concludes that no further action is required at this time. If additional information is received, the complaint file wil

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946358 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933056 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  The Biomedical Engineer (BME) reported that the V60 Ventilator stand had a broken locking caster. There was no patient involvement when the issue occurred. No patient impact and/or harm was reported. No user impact and/or harm was reported.A Philips Remote Service Engineer (RSE) provided assistance to the BME, and it was reported that the issue was replicated during diagnostics. The BME was provided with the part numbers (locking casters, and caster wrench) for replacement parts. The issue was replicated/confirmed during diagnostics. Based on the details provided, the damaged castors are considered a malfunction and can become a stability issue for the device. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931993 ↗
• MalfunctionSep 29, 2026Tidal Volume Fluctuations

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931305 ↗
• MalfunctionSep 25, 2026Device Sensing Problem

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the device had a ventilator (vent) inoperative (INOP); a 1009 "Pressure regulation high" error was present. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported. The device was removed from service.Based on the case information provided, the device did not meet product specifications. The alleged malfunction impacted the user¿s ability to use the device properly.The customer called technical support to report that the device had a vent INOP with a 1009 "Pressure regulation high" error. The Remote Service Engineer (RSE) performed troubleshooting with the customer, but the 1009 error could not be duplicated. The RSE reviewed the suggested repair for the 1009 error with the customer according to the V60 service manual and verified that the Proximal and Machine pressure lines were routed correctly. The RSE also advised the customer to perform Performance Verification Test (PVT) testing (specifically pressure testing) and address any issues found. The customer informed the RSE that the air Inlet filter was replaced but app

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896795 ↗
• MalfunctionSep 25, 2026Excessive Heating

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the device had a high temperature blower motor error. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported.Based on the case information provided, the device did not meet product specifications. The alleged malfunction impacted the user¿s ability to use the device properly.The customer called technical support to report a "blower temperature high" alarm error. No accessories, including third-party devices, were being used that may have contributed to the issue. The customer checked the event log but was unable to verify the error in the event log. After powering on the device in normal operational mode and letting it run for over 30 minutes, the customer did not discover any alarms. The Remote Service Engineer (RSE) informed the customer of the recommended repair per the V60 service manual if the high blower temperature error reoccurs. The customer noted that further testing will be performed. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896793 ↗
• MalfunctionSep 24, 2026Inadequate User Interface

  Philips received a complaint by a Biomedical Engineer (BME) on the V60 indicating a device malfunction as touchscreen calibration failed. There was no patient involvement at the time the issue was discovered as the issue occurred during Preventive Maintenance (PM). No patient or user harm was reported. Based on the case information provided, the device did not meet product specifications. The alleged malfunction impacted the user¿s ability to use the device properly. A Biomedical Engineer (BME) discovered that touchscreen calibration failed during Preventive Maintenance (PM) and found that the replacement touchscreen needed to be ordered. Upon receiving the replacement touchscreen, the BME replaced the defective touchscreen and performed the Extended Self-Test (EST), after which the issue was resolved. The touchscreen replacement indicates that the cause of the malfunction was ultimately due to a faulty touchscreen replacement that needed to be replaced for repair. The device passed the required Performance Verification tests per Philips standard and was returned to service. No other malfunction was found. The investigation concludes that no further action is required at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884067 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840378 ↗
• MalfunctionSep 17, 2026Failure to Sense

  The customer reported that the V60 Ventilator displayed a "Machine and Proximal Pressure Sensors Failed" error code (1007). There was no patient involvement when the issue occurred. No patient impact and/or harm was reported. No user impact and/or harm was reported.The customer inquired about the part number for a replacement Data Acquisition (DA) to Motor Controller (MC) cable; during the call, there was no allegation of malfunction reported. A follow up was performed with the customer, and it was reported that the device displayed a "Machine and Proximal Pressure Sensors Failed" error code (1007). It was reported that the Data Acquisition (DA) board, and Gas Delivery System (GDS) were replaced for preventative maintenance; after replacement of the parts, the customer saw the error code. The customer attempted to replace the DA to motor controller (MC) cable, but the issue was not resolved. The old DA board was then reinstalled, and the issue was resolved. It was determined that the replacement DA board was defective out of box (DEFOA). The issue was replicated/confirmed by the customer. The customer reported that the old DA board was reinstalled to fix the issue. It was noted tha

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805919 ↗
• MalfunctionSep 3, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596350 ↗
• MalfunctionAug 27, 2026Unintended Power Up

  A Biomedical Engineer (BME) reported that a V60 ventilator powered on by itself without patient involvement, resulting in no patient or user impact or harm. A Philips Remote Service Engineer (RSE) assisted with troubleshooting, during which the uncommanded power-on issue was successfully replicated and confirmed. The RSE mapped out the power switch electrical circuit path¿encompassing the power switch overlay, the user interface (UI) assembly printed circuit board assembly (PCBA), and the power management (PM) PCBA¿and advised the BME to isolate the system by disconnecting the battery. When tested strictly on alternating current (AC) power, the BME reported that the device no longer powered on by itself. The RSE then instructed the BME to monitor the ventilator for several hours on AC power; if the issue does not recur, the battery should be replaced, but if the auto-power behavior returns, the BME must trace the previously discussed signal path. The BME was provided with the part number for a replacement battery, and the final investigation and disposition remain pending.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479711 ↗
• MalfunctionAug 18, 2026Display or Visual Feedback Problem

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the screen was not working properly. There was no patient involvement at the time the issue was discovered as the issue occurred during Preventive Maintenance (PM) evaluation. No patient or user harm was reported.The customer called technical support to report that the Liquid Crystal Display (LCD) assembly, NEC LCD cable, User Interface (UI) Printed Circuit Board Assembly (PCBA) to LCD cable, UI PCBA, and LCD tray needed to be ordered. Per the customer communication on (b)(6)2026, the parts were used to address an improperly working screen. The V60 service manual (Revision T) was used in diagnosing the issue. Once the LCD assembly, NEC LCD cable, UI PCBA to LCD cable, UI PCBA, and LCD tray were replaced, the issue was resolved as the device operated as intended per the manufacturer's specifications. The device passed the required Performance Verification tests per Philips standard and was returned to service. No other malfunction was found. The investigation concludes that no further action is required at this time. If additional information is received, the complaint file will be reopened.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304332 ↗
• MalfunctionJul 6, 2026Tidal Volume Fluctuations

  PHILIPS RECEIVED A CUSTOMER COMPLAINT REGARDING A V60 VENTILATOR MALFUNCTION WHERE THE DEVICE FAILED TO SENSE ANY PATIENT VOLUMES. AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY IN USE ON A PATIENT, BUT NO HARM TO THE PATIENT OR USER WAS REPORTED. THE DEVICE WAS PROMPTLY TAKEN OUT OF SERVICE, AND THE CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT THE VOLUME SENSING ISSUE. THE USER ENCOUNTERED NO ERROR CODES OR ERROR MESSAGES DURING THE EVENT, AND NO ACCESSORIES OR THIRD-PARTY DEVICES CONTRIBUTED TO THE PROBLEM. A REMOTE SERVICE ENGINEER (RSE) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND CONFIRMED THE ISSUE. BECAUSE THE DEVICE WAS UNDER CONTRACT, THE CUSTOMER REQUESTED ONSITE SERVICE. IN RESPONSE, THE RSE PROVIDED THE CUSTOMER WITH A BENCH REPAIR DOCUMENT AND CREATED A WORK ORDER TO DISPATCH AN AUTHORIZED SERVICE PROVIDER (ASP) TO EVALUATE AND REPAIR THE MACHINE ONSITE.UPON ARRIVING ONSITE, THE ASP REPLICATED THE REPORTED ISSUE AS SOON AS THEY POWERED ON THE DEVICE, OBSERVING THAT THE SCREEN FAILED TO SHOW PROPER DATA VALUES AND INSTEAD DISPLAYED ONLY ASTERISKS. TO TROUBLESHOOT, THE ASP ATTACHED A LUNG TESTING KIT AND CONFIRMED THAT THE DEVICE WAS NOT READING ANY VOLUME VALUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25724913 ↗
• MalfunctionJul 1, 2026No Display/Image

  PHILIPS RECEIVED A PRODUCT COMPLAINT REGARDING A V60 VENTILATOR THAT PRESENTED WITH A BLANK DISPLAY WHILE OUTSIDE OF CLINICAL USE. NO PATIENT OR USER HARM OCCURRED AS A RESULT OF THIS ISSUE. THE CUSTOMER REPORTED TO A REMOTE SERVICE ENGINEER (RSE) THAT WHILE THE DEVICE SUCCESSFULLY POWERED ON, THE SCREEN REMAINED COMPLETELY BLANK AND UNREADABLE. THE RSE ADVISED THAT THE FACILITY COULD EITHER REPLACE THE ENTIRE USER INTERFACE (UI) ASSEMBLY OR ORDER INDIVIDUAL UI COMPONENTS, AND SUBSEQUENTLY PROVIDED THE REQUESTED PART NUMBERS FOR THE FULL ASSEMBLY. THE OFFICIAL INVESTIGATION INTO THE ROOT CAUSE OF THE DISPLAY FAILURE REMAINS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678845 ↗
• MalfunctionJun 30, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY A BIOMEDICAL ENGINEER (BME) ON THE V60 (SOFTWARE VERSION 3.10) INDICATING THAT THE LIQUID CRYSTAL DISPLAY (LCD) NEEDED TO BE REPLACED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. AS OF JUNE 15, 2026, AN AUTHORIZED SERVICE PROVIDER (ASP) WAS DISPATCHED ONSITE TO EVALUATE AND REPAIR THE DEVICE, AND UPON ARRIVAL, THE ASP PERFORMED TEST AND VERIFICATION (T&V) TESTS PER THE V60 SERVICE MANUAL AND CALIBRATED LCD SCREEN. THE ASP FOUND THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS NOT FUNCTIONING; HOWEVER, THE TOUCHSCREEN WAS ABLE TO BE CALIBRATED AND RECOGNIZE TOUCHES. NO ERROR CODES/ERROR MESSAGES WERE ENCOUNTERED BY THE USER, AND NO ACCESSORIES, INCLUDING THIRD-PARTY DEVICES, WERE BEING USED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. ULTIMATELY, THE ASP FOUND THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY NEC LCD CABLE THAT NEEDED TO BE REPLACED FOR REPAIR; AFTER PERFORMING THE REPLACEMENT, THE ASP VERIFIED THAT THE ISSUE WAS RESOLVED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669536 ↗
• MalfunctionJun 30, 2026Failure to Sense

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A PATIENT DISCONNECT HAD OCCURRED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. IT WAS REPORTED THAT A PATIENT DISCONNECT HAD OCCURRED. THE UNIT WAS SENT TO BENCH REPAIR FOR FURTHER EVALUATION. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668923 ↗
• MalfunctionJun 30, 2026Mechanical Problem

  PHILIPS RECEIVED A COMPLAINT BY AN AUTHORIZED SERVICE PROVIDER (ASP) ON THE V60 (SOFTWARE VERSION 3.10) INDICATING THAT THE BOTTOM FEET WERE MISSING, CAUSING THE DEVICE TO SIT LOOSELY AND UNSTABLE ON THE STAND. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. AS OF JUNE 15, 2026, AN AUTHORIZED SERVICE PROVIDER (ASP) WAS DISPATCHED ONSITE TO EVALUATE THE DEVICE, AND UPON ARRIVAL, THE ASP OBSERVED THAT THE DEVICE SAT LOOSELY AND WAS UNSTABLE ON THE STAND AS THE BOTTOM FEET WERE MISSING. ULTIMATELY, THE ASP INSTALLED NEW BOTTOM FEET AND CENTRAL PROCESSING UNIT (CPU) TRAY COVER ON JUNE 18, 2026, AND AFTER PERFORMING A CHECK OF THE FEET, THE ASP VERIFIED THAT THE DEVICE WAS STABLE ON THE STAND. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE. NO OTHER MALFUNCTION WAS FOUND. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668921 ↗
• MalfunctionJun 30, 2026Power Problem

  PHILIPS RECEIVED A COMPLAINT REGARDING A V60 VENTILATOR THAT DISPLAYED AN AUXILIARY ALARM SUPPLY FAILED ALARM, THOUGH NO PATIENT OR USER HARM WAS REPORTED. AT THE TIME OF THE INCIDENT, THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE. DURING REMOTE TROUBLESHOOTING, THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THEY CHECKED THE VOLTAGES ON THE PNEUMATICS SCREEN AND NOTED NO ISSUES. BECAUSE THE PRODUCT MALFUNCTION COULD NOT BE DEFINITIVELY CONFIRMED REMOTELY, THE RSE REVIEWED THE V60 SERVICE MANUAL AND DETERMINED THAT A FAULTY MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS THE LIKELY CAUSE OF THE ALLEGED ISSUE. THE RSE THEN RECOMMENDED REPLACING THE MC PCBA AND PROVIDED THE NECESSARY PART INFORMATION. IN A GOOD FAITH EFFORT RESPONSE RECEIVED ON JUNE 29, 2026, THE CUSTOMER CONFIRMED THAT THE PART WAS ORDERED, RECEIVED, AND SUCCESSFULLY INSTALLED. FOLLOWING THE COMPONENT REPLACEMENT, THE CUSTOMER COMPLETED PERFORMANCE TESTING IN ACCORDANCE WITH THE SERVICE MANUAL, AND THE DEVICE WAS CONFIRMED TO BE FULLY FUNCTIONAL AND RETURNED TO USE. CONSEQUENTLY, THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME, THOUGH THE COMPLAINT FILE WILL BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668480 ↗
• MalfunctionJun 26, 2026Unstable

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT ONE OF THE STAND'S MOUNTING SCREWS (THUMBWHEELS) THREADS WAS STRIPPED; ALSO, ONE OF THE FEET WAS MISSING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS UNAVAILABLE FOR CLINICAL USE AS IT WAS REMOVED FROM SERVICE. PER THE GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED ON JUNE 5, 2026, THE BIOMEDICAL ENGINEER (BME) STATED THAT THE DEVICE WAS LOOSE ON THE STAND AS IT WAS MISSING A BLACK RUBBER FOOT; ALSO, THE SCREW THAT SECURED THE V60 TO THE STAND WAS STRIPPED. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER TO CHECK THE CONDITION OF THE THREADS THAT THE STAND'S THUMBWHEELS SCREW INTO AND PROVIDED THE CUSTOMER WITH THE PART NUMBERS OF THE REPLACEMENT THUMBWHEEL AND BOTTOM FOOT KIT FOR REPAIR. THE BME WAS TOLD THAT THE SCREW WAS OBSOLETE AND FEET WERE BACKORDERED; HOWEVER, THE BME WAS ABLE TO SECURE THE DEVICE TO THE CART SATISFACTORILY AND RETURNED THE DEVICE TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637759 ↗
• MalfunctionJun 26, 2026Unintended Power Up

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE UNIT POWERED ON BY ITSELF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE UNIT POWERED ON BY ITSELF. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE. THE PHILIPS ASP PLUGGED THE UNIT IN AND LEFT IT FOR 15 TO 20 MINUTES, TURNED ON THE DEVICE LATER ON FOR 15 TO 20 MINUTES, THEN LEFT THE DEVICE RUNNING FOR 15 TO 20 MINUTES. THE PHILIPS ASP DETERMINED THAT THE INTERMITTENT ISSUE WAS DUE TO A FAULTY USER INTERFACE (UI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) PER THE SERVICE MANUAL. THE PHILIPS ASP WAS UNABLE TO REPLACE THE UI PCBA DUE TO A DEAD PART NUMBER. THE PHILIPS ASP THEN REPLACED THE POWER SWITCH OVERLAY, SWITCH PCBA, AND POWER MANAGEMENT (PM) PCBA. THE CUSTOMER REPLACED THE POWER SWITCH OVERLAY, SWITCH PCBA, AND PM PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637200 ↗
• MalfunctionJun 26, 2026Failure to Sense

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE V60 VENTILATOR DISPLAYED A "CHECK VENT: PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED" ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT IMPACT AND/OR HARM WAS REPORTED. THE USER WAS RESTRICTED FROM USING THE DEVICE, DUE TO THE DEVICE BEING REMOVED FROM SERVICE. DURING TROUBLESHOOTING WITH THE BME, THE REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE ISSUE WAS REPLICATED. THE BME CONFIRMED THAT THE ERROR CODE WAS RECORDED IN EVENT LOG. THE BME WAS PROVIDED WITH THE FOLLOWING MANUFACTURER'S RECOMMENDED REPAIR - VERIFY PIN ALIGNMENT BETWEEN SOLENOIDS AND THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), REPLACE THE PROXIMAL AUTO-ZERO SOLENOID (SOL 3 AND SOL 4), REPLACE THE DA PCBA. THE BME REPORTED THAT THE PIN ALIGNMENT WOULD BE CHECKED AND CALL BACK IF ANY ADDITIONAL ASSISTANCE WAS NEEDED. THE ISSUE WAS REPLICATED, AND THE ERROR CODE WAS CONFIRMED IN THE EVENT LOG. BASED ON THE DETAILS PROVIDED, A MALFUNCTION OCCURRED, AND THE DEVICE DISPLAYED A "CHECK VENT: PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED" ERROR CODE. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635629 ↗
• MalfunctionJun 25, 2026Unstable

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE TOP PLATFORM WAS DAMAGED AND NEEDED TO BE REPLACED. PER THE GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED ON JUNE 16, 2026, THE TOP PLATFORM WAS SEVERELY DAMAGED, AND THE DEVICE WAS UNSTABLE ON THE STAND. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. AN AUTHORIZED SERVICE PROVIDER (ASP) WAS PREVIOUSLY DISPATCHED ONSITE, AND UPON ARRIVAL, THE ASP ULTIMATELY REPLACED THE TOP PLATFORM FOR REPAIR, AFTER WHICH THE ISSUE WAS RESOLVED. FOLLOWING THE TOP PLATFORM REPLACEMENT, THE ASP RETURNED THE DEVICE TO SERVICE AS IT PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD. NO OTHER MALFUNCTION WAS FOUND. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628463 ↗
• MalfunctionJun 24, 2026Failure to Transmit Record

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE RS232 CABLE WAS NOT CONNECTED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE RS232 CABLE WAS NOT CONNECTED. IT WAS STATED THAT THE RS232 CABLE WAS NOT REATTACHED AFTER EPIC TESTING. THE BIOMED THEN REATTACHED THE RS232 CABLE TO THE UNIT SO THAT THE UNIT CAN BE CONNECTED TO CERNER BOX UNTIL EPIC INTEGRATION. THE DEVICE WAS RETURNED TO SERVICE AFTER. THE BIOMED REATTACHED THE RS232 CABLE TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE ISSUE WAS DETERMINED TO BE A MALFUNCTION. THE REPORTED ISSUE OF THE RS232 CABLE NOT BEING ATTACHED WAS CONFIRMED VIA VISUAL INSPECTION. THE CAUSE OF THE MALFUNCTION WAS THE CUSTOMER NOT REATTACHING THE RS232 CABLE AFTER EPIC TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616701 ↗
• MalfunctionJun 24, 2026Failure to Charge

  PHILIPS RECEIVED A COMPLAINT BY THE BIOMEDICAL ENGINEER (BME) ON THE V60 INDICATING THAT THE DEVICE NEEDED A BATTERY AND POWER CORD FOLLOWING PREVENTIVE MAINTENANCE (PM). THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE BIOMEDICAL ENGINEER (BME) CALLED TECHNICAL SUPPORT TO REPORT THAT THE DEVICE NEEDED A BATTERY AND POWER CORD FOLLOWING PREVENTIVE MAINTENANCE (PM). THE BATTERY (2013) NEEDED TO BE REPLACED AS IT WAS MORE THAN THE RECOMMENDED AGE 5 YEARS OLD. THE REPLACEMENT OF THE BATTERY WOULD BE ALIGNED TO THE PERIODIC MAINTENANCE PROCEDURE SPECIFIED IN THE V60 SERVICE MANUAL, WHICH INDICATES THAT THE BATTERY REQUIRES REPLACEMENT EVERY 5 YEARS TO ENSURE PROPER SYSTEM PERFORMANCE. PER THE GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED ON JUNE 3, 2026, THE BATTERY WAS NOT CHARGING WHEN THE DEVICE WAS PLUGGED IN. WHEN THE BME POWERED ON THE DEVICE, THE ISSUE WAS CONFIRMED AS THERE WAS NO POWER; THE BATTERY "¿OHMED OUT", AND THE POWER CORD WAS FAULTY AS SOMETHING WAS BROKEN ON THE INSIDE OF THE POWER CORD OR PLUG. THERE WERE NO EXPOSED WIRES, AND THE DEVICE DID NOT FAIL THE ELECTRICAL SAFETY TEST. THE BME ULTIMATELY PLACED AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612968 ↗
• MalfunctionJun 24, 2026Failure to Run on Battery

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 (SOFTWARE VERSION 3.20) INDICATING A DEVICE MALFUNCTION AS THE DEVICE FAILED TO POWER ON AND DISPLAYED A 1124 "BATTERY FAILED" ALARM ERROR MESSAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE DEVICE FAILED TO INITIALIZE AND DISPLAYED A 1124 "BATTERY FAILED" ALARM ERROR MESSAGE. THE DEVICE DID NOT COMPLETE STARTUP AND ENTERED A SYSTEM RESTRICTED STATE, PREVENTING THE USER TO OPERATE THE DEVICE AND PERFORM PREVENTIVE MAINTENANCE OR FUNCTIONAL TESTING. NO ACCESSORIES, INCLUDING THIRD-PARTY DEVICES, WERE BEING USED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. AN AUTHORIZED SERVICE PROVIDER (ASP) WAS DISPATCHED ONSITE TO EVALUATE AND REPAIR THE DEVICE, AND UPON ARRIVAL, THE ASP WAS ABLE TO REPLICATE THE ISSUE AFTER EVALUATING THE ERROR LOGS AND VERIFYING THAT THE 1124 ERROR CODE WAS LOGGED. THE ASP DEEMED THAT THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) NEEDED TO BE REPLACED ACCORDING TO THE V60 SERVICE MANUAL. SHORTLY AFTER, ANOTHER ASP ARRIVED ONSITE TO SERVICE THE DEVICE, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610756 ↗