Philips Respironics V60 (REF 1053616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00884838020047), received between Aug 16, 2018 and Apr 17, 2026 — classified as 3 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT REGARDING A V60 DEVICE THAT WAS OPERATING ON BATTERY POWER EVEN WHEN CONNECTED TO AC POWER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT OR IMPACT AT THE TIME THE ISSUE WAS IDENTIFIED, AND THE DEVICE ALARM/ALERT FUNCTIONED AS INTENDED. THE DEVICE WAS EVALUATED ONSITE, AND TESTING CONFIRMED THE REPORTED ISSUE. UPON INSPECTION, THE PROBLEM WAS ATTRIBUTED TO A FAULTY POWER CORD CABLE. THE CUSTOMER, WITH ASSISTANCE FROM A REMOTE SERVICE ENGINEER (RSE), CONFIRMED THE ISSUE. AS A CORRECTIVE ACTION, THE POWER CORD WAS REPLACED. FOLLOWING REPLACEMENT, THE DEVICE WAS RETESTED, AND NORMAL OPERATION WAS RESTORED, WITH BATTERY VOLTAGE AND ELECTRICAL MEASUREMENTS WITHIN ACCEPTABLE LIMITS. THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS CONFIRMED TO MEET PRODUCT SPECIFICATIONS BEFORE BEING 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. BASED ON THE INFORMATION PROVIDED AND SERVICE PERFORMED, IT WAS CONFIRMED THAT THE UNIT DID NOT MEET PRODUCT SPECIFICATIONS AT THE TIME OF FAILU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911549 ↗
• MalfunctionMar 31, 2026Unstable

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR'S CENTRAL PROCESSING UNIT (CPU) TRAY COVER HAD A PIECE OF METAL BROKEN OFF. THE MOUNTING THREADS ON THE CPU TRAY COVER ARE BAD. THE CUSTOMER WAS THEREFORE UNABLE TO SECURE THE DEVICE TO THE STAND. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE REMOTE SERVICE ENGINEER PROVIDED THE CUSTOMER WITH THE PART NUMBER FOR A REPLACEMENT CENTRAL PROCESSING UNIT (CPU) TRAY COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747626 ↗
• MalfunctionDec 23, 2025Failure to Charge; Failure to Charge

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE POWER CORD WAS GOOD, BUT THE INDICATOR LIGHT EMITTING DIODE (LED) ON THE FRONT PANEL WASN'T SHOWING WHEN PLUGGED IN. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THE BATTERY WASN'T CHARGING, AND THE POWER INDICATOR LIGHT WASN'T ON WHEN PLUGGED INTO POWER. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. THERE WAS NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THE BATTERY WASN'T CHARGING, AND THE POWER INDICATOR LIGHT WASN'T ON WHEN PLUGGED INTO POWER. THE CUSTOMER CHECKED THE POWER AT THE J1 CONNECTOR OF THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND FOUND THE 24-VOLT DIRECT CURRENT (DC) TO BE GOOD. THE CUSTOMER RECONNECTED THE CONNECTOR TO THE J1 AND RECONNECTED ALTERNATING CURRENT (AC) POWER. THE CUSTOMER NOW OBSERVED THE AMBER LED WAS ILLUMINATED AND THE BATTERY LED WAS STEADY. THE DEVICE POWERED ON INTO DIAGNOSTIC MODE AND THE CUSTOMER VERIFIED THAT ALL THE VOLTAGES SHOWED AS GOOD IN THE PNEUMATICS SCREEN WITH THE BATTERY SHOWING 16.5 VOLTS DC, FULLY CHARGED. THE CUSTOMER WAS ADVISED BY THE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881954 ↗
• MalfunctionSep 10, 2025Unstable; Unstable

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS LOOSE HARDWARE ON THE V60 STAND. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THERE WAS LOOSE HARDWARE ON THE V60 STAND. THE CUSTOMER REQUESTED THE PART NUMBER OF THE LATCH ON THE V60 STAND. THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE LATCH. DEVICE EVALUATION AND REPAIR ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017941 ↗
• MalfunctionAug 7, 2025Obstruction of Flow; Obstruction of Flow

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE UNIT WAS GIVING A PATIENT CIRCUIT OCCLUDED ERROR. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE REMOTE SERVICE ENGINEER (RSE) AND CUSTOMER PERFORMED A TROUBLESHOOT. THE CUSTOMER INFORMED THE RSE THAT THE DEVICE WAS ON BUT DID NOT BLOW ANYTHING. THE RSE INSTRUCTED THE CUSTOMER TO GO INTO SERVICE MODE, CHECK THE PNEUMATICS SCREEN, AND IT WAS DISCOVERED THAT THE ROTATIONS PER MINUTE (RPM) FOR THE BLOWER WAS AT 3000. THE RSE THEN HAD THE CUSTOMER ADJUST THE PRESSURE AND THE RPMS STAYED AT 3000. THE RSE ADVISED THE CUSTOMER THAT THEY WERE GETTING A BLOWER STALLED ERROR. THE RSE INFORMED THE CUSTOMER A BLOWER ASSEMBLY WAS REQUIRED. THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE BLOWER ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742164 ↗
• MalfunctionMay 21, 2025Material Integrity Problem; Material Integrity Problem

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE ORIGINAL U-STAND HAD WORN SPOTS ON THE RUBBER CASTERS, AND THE CART DID NOT ROLL. 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 ORIGINAL U-STAND HAD WORN SPOTS ON THE RUBBER CASTERS, AND THE CART DID NOT ROLL. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER THAT THE U-STAND AND ASSOCIATED PARTS ARE NO LONGER AVAILABLE, AND THE V60 WOULD NEED TO BE CONVERTED TO A NEWER STYLE STAND TO CORRECT THE ISSUE. THE RSE ALSO GAVE THE CUSTOMER THE INSTRUCTIONS AND PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE REPLACEMENT V60 STAND PARTIALLY ASSEMBLED, BOTTOM FOOT KIT, AND RETENTION PLATE PER THE V60 MANUAL. RESOLUTION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064792 ↗
• MalfunctionDec 3, 2024Display Difficult to Read; Display Difficult to Read

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A DIM DISPLAY. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) INFORMED THE CUSTOMER TO UPDATE THE DISPLAY OR REPLACE THE USER INTERFACE (UI) ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH THE PART NUMBER FOR A REPLACEMENT UI ASSEMBLY. THE CUSTOMER REACHED BACK OUT TO THE SERVICE ENGINEER AND REQUESTED ON-SITE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20837104 ↗
• MalfunctionNov 18, 2024Complete Loss of Power; Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DEVICE INTERMITTENTLY SWITCHED TO BATTERY POWER AND THEN BACK TO ALTERNATING CURRENT (AC) POWER WHILE CYCLING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED AS THE ISSUE OCCURRED DURING PREVENTIVE MAINTENANCE (PM) SERVICE. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE DEVICE INTERMITTENTLY SWITCHED TO BATTERY POWER AND THEN BACK TO ALTERNATING CURRENT (AC) POWER WHILE CYCLING. THE CUSTOMER NOTED THAT THE BATTERY IS A PHILIPS BATTERY (DATED 2020) AND STATED THAT THE ISSUE MAY BE DUE TO THE FACT THAT THE PATIENT OUTLET IS OCCLUDED; ALTERNATE POWER CORDS AND AC OUTLETS WERE TRIED, AND BOTH LIGHT EMITTING DIODES (LEDS) ON THE FRONT PANEL WERE ILLUMINATED SOLID. THE CUSTOMER REMOVED THE POWER SUPPLY SHROUD BUT COULD NOT DETERMINE IF 110AC VOLTS WAS PRESENT. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER ON THE SIGNAL PATH FOR AC AND DC POWER AND VOLTAGE TEST POINTS PER THE V60 SERVICE MANUAL AND INSTRUCTED THE CUSTOMER TO CHECK THE PINS WITHIN ALL CONNECTORS FOR SEATING--IF ALL POWER SOURCES ARE GOOD, THE RSE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20710493 ↗
• MalfunctionOct 21, 2024Unstable; Unstable

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT IT IS WOBBLY ON THE STAND. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. PER GOOD FAITH EFFORT (GFE), IT WAS CONFIRMED BY THE CUSTOMER THAT THERE IS NO ISSUE WITH THE V60 ITSELF. IT WAS OBSERVED THAT THE V60 WAS A BIT WOBBLY ON THE STAND. INVESTIGATED AND FOUND THAT ONE OF THE THUMBWHEEL SCREWS WAS BROKEN OFF AND THE OTHER WAS BADLY BENT. THE THUMBWHEEL SCREWS HAVE BEEN REPLACED AND THE V60 SECURED TO THE STAND. 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 20494513 ↗
• MalfunctionOct 7, 2024Failure to Run on Battery; Failure to Run on Battery

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS BATTERY FAILURE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE DEVICE'S POWER MANAGEMENT (PM) BOARD WAS REPLACED FOR FIELD CHANGE ORDER REMEDIATION, AND THE DEVICE ALARMED FOR BATTERY FAILURE. THE CUSTOMER HAD AFTERMARKET BATTERIES. A GOOD FAITH EFFORT RESPONSE WAS RECEIVED AND BATTERY ALARM AFTER PM BOARD REPLACEMENT AND ERROR CODE 1124 IN THE DEVICE'S LOG HISTORY FOR BATTERY FAILURE WAS CONFIRMED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391106 ↗
• MalfunctionSep 18, 2024No Display/Image; No Display/Image

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT WHILE THE DEVICE WAS IN USE ON A PATIENT, THE DISPLAY SCREEN WENT BLANK. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT WHILE THE DEVICE WAS IN USE ON A PATIENT, THE DISPLAY SCREEN WENT BLANK-- ALTHOUGH THE DEVICE CONTINUED TO OPERATE AND CYCLE BREATHS, NO PARAMETERS WERE VISIBLE; HOWEVER, ALARMS WERE NOT ACTIVATED, AND THE TOUCHSCREEN REMAINED OPERATIONAL. THE BIOMEDICAL ENGINEER (BME) CONFIRMED THE REPORTED ISSUE AND FOUND THAT THE ISSUE WAS POSSIBLY DUE TO THE FACT THAT THE CUSTOMER HAD THE ORIGINAL FIRST-GENERATION LIQUID CRYSTAL DISPLAY (LCD) INSTALLED. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER TO REPLACE THE USER INTERFACE (UI) DISPLAY ASSEMBLY WITH THE SECOND-GENERATION LCD TO CORRECT THE ISSUE AND PROVIDED THE CUSTOMER WITH THE PART NUMBER AND PRICE OF THE REPLACEMENT UI ASSEMBLY FOR REPAIR. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246576 ↗
• MalfunctionSep 16, 2024Inadequate User Interface; Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY THE BIOMED CUSTOMER ON THE V60 INDICATING THAT THE DEVICES TOUCHSCREEN KEPT LOSING CALIBRATION. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THAT THE BIOMED CUSTOMER CALIBRATED THE SCREEN A FEW TIMES, AND OVER TIME IT WOULD BE OUT OF CALIBRATION AGAIN. THE RSE PROVIDED PARTS ID FOR THE TOUCHSCREEN. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20228811 ↗
• MalfunctionSep 9, 2024Excessive Heating; Excessive Heating

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A BLOWER TEMPERATURE TOO HIGH ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169618 ↗
• MalfunctionAug 27, 2024Display Difficult to Read; Display Difficult to Read

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DISPLAY WAS DIM. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE DISPLAY WAS DIM. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER TO REPLACE THEIR HYDIS DISPLAY WITH A V60 USER INTERFACE (UI) ASSEMBLY. THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE UI ASSEMBLY TO ORDER AND REPLACE. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078519 ↗
• MalfunctionAug 23, 2024Failure to Power Up; Complete Loss of Power; Failure to Power Up; Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE WOULD NOT FULLY POWER UP, BLINKED, AND GAVE AN AUDIBLE ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THAT THE CUSTOMER START TROUBLESHOOTING BY REPLACING THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). IT WAS ADVISED TO ATTEMPT REPLACING THE USER INTERFACE (UI) ASSEMBLY IF THE PM PCBA DID NOT RESOLVE THE ISSUE. THE CUSTOMER CALLED BACK AND COMMUNICATED THE INITIAL COMPLAINT AT THE CUSTOMER SITE WAS A BURNING SMELL COMING FROM THE DEVICE DURING SETUP. THE DEVICE WAS THEN BROUGHT TO THE BIOMEDICAL ENGINEER (BME) FOR TESTING. DURING TROUBLESHOOTING, AT POWER ON THE DISPLAY BRIEFLY TURNED ON, AN ALARM ACTIVATED, AND NO BREATHS BEGAN CYCLING. THE DEVICE THEN GOES BLACK. THE CUSTOMER BME VERIFIED THAT THERE WERE 24 VOLTS DIRECT CURRENT (DC) PRESENT AT THE J1 CONNECTOR OF THE POWER SUPPLY AND THE FRONT PANEL LIGHT EMITTING DIODES (LEDS) WERE ILLUMINATED. THE CUSTOMER INSTALLED A KNOWN WORKING PM PCBA, AND THE DEVICE AGAIN TURNED ON, PRODUCED AN ALARM, DID NOT CYCLE BREATHS, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052052 ↗
• MalfunctionJun 26, 2024Failure to Power Up; Failure to Power Up

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WAS NOT TURNING ON. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR WAS NOT TURNING ON. THE BIOMEDICAL ENGINEER (BME) STATED THAT THE DEVICE WOULD NOT TURN ON. THE BME THEN DETERMINED THAT THE BATTERY WAS DRAINED, AND THE DEVICE WAS NOT OPERATING ON ALTERNATING CURRENT (AC) POWER. THE BATTERY WAS REPLACED, AND THE DEVICE WAS ABLE TO POWER ON. IT WAS THEN NOTED THAT THE DEVICE POWERED DOWN, DUE TO OPERATING ON BATTERY. DURING TROUBLESHOOTING, THE RSE PROVIDED INSTRUCTIONS TO THE CUSTOMER PER THE SERVICE MANUAL. THE BME CONFIRMED THAT THE POWER SUPPLY WAS BAD. THE CUSTOMER WAS PROVIDED WITH THE PART NUMBER FOR A REPLACEMENT POWER SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620288 ↗
• MalfunctionJun 18, 2024Failure to Sense; Failure to Sense

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60, INDICATING THAT DEVICE STARTED LOGGING ERROR CODE 110B PROXIMAL PRESSURE SENSOR AUTOZERO FAILED MESSAGE DURING PERFORMANCE VERIFICATION TESTING (PVT). IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE RSE ADVISED THE CUSTOMER THAT THE LATEST VERSION OF THE SERVICE MANUAL IS VERSION T. DIAGNOSTIC CODE 110B - PROXIMAL PRESSURE SENSOR AUTOZERO FAILED. THE PROXIMAL PRESSURE IS NOT MEASURED, AND PRESSURE-RELATED ALARMS ARE COMPROMISED. 1. VERIFY PIN ALIGNMENT BETWEEN SOLENOIDS AND THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). 2. REPLACE THE PROXIMAL AUTO-ZERO SOLENOID (SOL 3 AND SOL 4). 3. REPLACE THE DA PCBA AND THE SOLENOID VALVE. RESOLUTION AND DISPOSITION ARE PENDING - INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558710 ↗
• MalfunctionJun 14, 2024Power Problem; Power Problem

  PHILIPS RECEIVED A COMPLAINT REPORTING AN AUXILIARY ALARM SUPPLY FAILED ON THE V60 VENTILATOR. THE DEVICE WAS REPORTED TO BE NOT IN CLINICAL USE. THERE WAS NO REPORT OF HARM. THERE WAS NO PATIENT OR USER IMPACT. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE AND CONFIRMED DIAGNOSTIC CODE 1115 (AUXILIARY ALARM SUPPLY FAILED) IN THE EVENT LOG. THE ASP REPORTED THE USER INTERFACE (UI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED. THE DEVICE WAS OPERATIONAL AND RETURNED TO SERVICE AFTER REPAIRS WERE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543334 ↗
• MalfunctionApr 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60, INDICATING THAT THERE WAS A USER INTERFACE (UI) ISSUE THAT REQUIRED THE DISPLAY ASSEMBLY TO BE UPDATED. AT THIS TIME, IT UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THERE WAS A USER INTERFACE (UI) ISSUE THAT REQUIRED THE DISPLAY ASSEMBLY TO BE UPDATED. THE CUSTOMER STATED THAT AFTER AN EXTENSIVE BACKORDER, THE UI DISPLAY WAS RECEIVED TO UPDATE THE DISPLAY ASSEMBLY. RESOLUTION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201803 ↗
• MalfunctionApr 18, 2024Complete Loss of Power; Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT FROM THE BIOMEDICAL ENGINEER (BME) ON THE V60 VENTILATOR INDICATING THAT A 1127 "OVP CIRCUIT FAILED" ALARM ERROR APPEARED ON THE SCREEN IN NORMAL MODE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE REMOTE SERVICE ENGINEER VERIFIED THAT THE 1127 ERROR CODE WAS LOGGED IN THE EVENT LOG AND ADVISED THE BME TO FOLLOW THE REPAIR PATH THAT IS DOCUMENTED IN THE V60 MANUAL. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140218 ↗
• MalfunctionApr 17, 2024Mechanical Problem; Mechanical Problem

  PHILIPS RECEIVED A COMPLAINT BY THE BIOMEDICAL ENGINEER (BME) ON THE V60, INDICATING THAT THE BLOWER MOTOR WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE BIOMEDICAL ENGINEER (BME) CALLED TECHNICAL SUPPORT TO REPORT THAT THE BLOWER MOTOR WAS NOT WORKING AND REQUESTED ASSISTANCE WITH TROUBLESHOOTING. THE BLOWER WAS CONNECTED TO THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND SHOWED 3000 RPM IN PNEUMATICS, BUT THERE WAS NO OUTPUT. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE BME TO EITHER SWAP THE MC PCBA FOR TROUBLESHOOTING AND REPLACE IT IF NEEDED OR REPLACE THE BLOWER ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127795 ↗
• MalfunctionApr 17, 2024Power Problem; Power Problem

  PHILIPS RECEIVED A COMPLAINT BY THE FIELD SERVICE ENGINEER (FSE) ON THE V60 INDICATING THAT WHILE SERVICING THE DEVICE, IT WAS OBSERVED THAT THERE WAS AN ERROR CODE 1115 CHECK VENT: AUX ALARM SUPPLY FAILED MESSAGE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE FSE REPLACED THE MOTOR CONTROLLER PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125815 ↗
• MalfunctionApr 17, 2024Failure to Run on Battery; Failure to Run on Battery

  PHILIPS RECEIVED A COMPLAINT BY THE FIELD SERVICE ENGINEER (FSE) ON THE V60 INDICATING THAT WHILE SERVICING THE DEVICE, IT WAS OBSERVED THAT THERE WAS AN ERROR CODE 1124 CHECK VENT: BATTERY FAILED MESSAGE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE FSE REPLACED THE BATTERY 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. BASED ON INFORMATION PROVIDED AND/OR SERVICE PERFORMED IT WAS CONFIRMED UNIT DID NOT MEET PRODUCT SPECIFICATIONS. IT WAS DETERMINED THAT THE BATTERY WAS THE CAUSE OF THE REPORTED ISSUE. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED. ALTHOUGH REQUESTED, THE DEFECTIVE PARTS WERE NOT RECEIVED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE PART IS RECEIVED AND EVALUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124632 ↗
• MalfunctionApr 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE FIELD SERVICE ENGINEER (FSE) ON THE V60 VENTILATOR INDICATING THAT WHILE SERVICING THE DEVICE, IT WAS OBSERVED THAT THE DEVICE HAD A SPI (SERIAL PERIPHERAL INTERFACE) BUS - 1107 & 1113, 110F FAILURE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED DURING SERVICING. IT WAS DETERMINED THE FAILING COMPONENT IS THE DATA ACQUISITION PCBA BOARD WHICH NEEDS TO BE REPLACED. THE FSE REPLACED THE DATA ACQUISITION PCBA BOARD TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079449 ↗
• MalfunctionApr 8, 2024Failure to Sense; Failure to Sense

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE IS GETTING AN ERROR CODE 1108-MACHINE PRESSURE SENSOR AUTOZERO FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED ERROR CODE 1108-MACHINE PRESSURE SENSOR AUTOZERO IN THE SIGNIFICANT EVENT LOG. THE FSE DETERMINED THE FAILING COMPONENT IS THE DATA ACQUISITION PCBA BOARD. THE FSE REPLACED THE DATA ACQUISITION PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061804 ↗