PHILIPS 1076716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,946 adverse event reports that list this exact device (DI 00884838025776), received between Dec 1, 2016 and Sep 29, 2026 — classified as 1 death, 33 injuries, 2,912 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (326 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 28, 2022Open, 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 · FDA record ↗

2. Jun 18, 2021Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,946 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Complete Loss of Power

  The customer reported that the V60 Ventilator displayed a "35V power supply fault" message. It was unknown how the issue was found. No patient impact and/or harm was reported. No user impact and/or harm was reported. It was reported that the V60 Ventilator displayed a "35V power supply fault" message. No testing was reported to have been performed to replicate the issue and/or determine the cause. The issue was confirmed by the customer. No testing was reported to have been performed by the customer. It was reported that the driver board was replaced to resolve the issue. The customer reported that the device was returned to normal. 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 details provided, a malfunction occurred, and the device displayed a "35V power supply failure" message. The cause of the malfunction was determined to be a failure in the driver board. A conclusion/root cause can not be provided at this time, as the suspected part has not been returned for further analysis. In the event the suspected part is received, the evaluation will be performed, and th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931868 ↗
• MalfunctionSep 28, 2026Failure to Sense

  On 16Sep2026, Philips received a complaint from the Second Provincial General Hospital of Guangdong Province on the V60 indicating a device malfunction as the device issued a "Proximal pressure sensor autozero failed" alarm while the department was preparing to use this ventilator. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported. Normal operation resumed after the device was replaced.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. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914316 ↗
• MalfunctionSep 17, 2026Inaccurate Delivery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808396 ↗
• MalfunctionSep 8, 2026Complete Loss of Power

  Philips received a complaint on the V60 ventilator indicating that there was a 35 Volt (V) power supply failure. It is unknown if the device was in 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 50670157 ↗
• MalfunctionAug 24, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418108 ↗
• MalfunctionJul 6, 2026Failure to Charge

  PHILIPS RECEIVED A CUSTOMER COMPLAINT REGARDING A V60 VENTILATOR INDICATING THAT THE INTERNAL BATTERY WAS DEFECTIVE AND COULD NOT HOLD A CHARGE. ON (B)(6) 2026, THE CUSTOMER STATED THAT THE DEVICE WOULD SHUT DOWN IMMEDIATELY WHENEVER IT WAS DISCONNECTED FROM THE ALTERNATING CURRENT (AC) POWER SUPPLY. NO PATIENT OR USER HARM WAS REPORTED, AND THE DEVICE WAS CONFIRMED TO BE OUTSIDE OF USE AT THE TIME THE PROBLEM OCCURRED. IN RESPONSE, A GOOD FAITH EFFORT (GFE) COMMUNICATION WAS RECEIVED FROM THE AUTHORIZED SERVICE PROVIDER (ASP). WHILE THE ASP DID NOT PROVIDE THE DIAGNOSTIC REPORT (DRPT) FROM THE TIME OF THE EVENT, THEY CLARIFIED THAT THE NECESSARY SERVICE HAS SINCE BEEN COMPLETED. THE ASP STATED THAT THE SPECIFIC INFORMATION FOR THE PARTS USED TO SERVICE THE DEVICE WAS ASKED BUT UNKNOWN (ASKU). HOWEVER, THE ASP CONFIRMED THAT THE DEVICE WAS SUCCESSFULLY RESTORED TO FULL FUNCTIONALITY AND HAS BEEN RETURNED TO ACTIVE HOSPITAL USE. THE INVESTIGATION CONFIRMS THAT A PRODUCT MALFUNCTION OCCURRED, BUT THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE SPECIFIC SERVICE PART INFORMATION WAS NOT PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25724911 ↗
• MalfunctionJun 22, 2026Gas/Air Leak

  PHILIPS RECEIVED A MESSAGE FROM THE SECOND PEOPLE'S HOSPITAL OF GUANGDONG PROVINCE STATING THAT THE DEVICE REPORTED A LOW AIR LEAK AND RISK OF REPEATED CO2 INHALATION WHEN THE DEPARTMENT WAS PREPARING TO USE IT ON (B)(6) 2026. ITS USE WAS DISCONTINUED. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578467 ↗
• MalfunctionJun 22, 2026Power Problem

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING A DEVICE MALFUNCTION AS THE DEVICE COULD NOT BE POWERED DOWN PROPERLY. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. ON JUNE 8, 2026, PHILIPS RECEIVED A MESSAGE FROM THE (B)(6) STATING THAT THE DEVICE COULD NOT BE POWERED DOWN PROPERLY WHEN THE DEPARTMENT WAS PREPARING TO USE IT ON APRIL 15, 2026. THE MANUFACTURER'S ENGINEER WAS CONTACTED FOR AN INSPECTION. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578200 ↗
• MalfunctionJun 18, 2026Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS LOW AIR LEAKAGE VOLUME. 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 THERE WAS LOW AIR LEAKAGE VOLUME. DURING REMOTE SERVICE, IT WAS SUSPECTED THAT THE CAUSE OF THE ISSUE COULD BE DUE TO THE GAS DELIVERY SYSTEM (GDS) AND SENSORS DURING REMOTE SERVICE. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE TO FURTHER EVALUATE THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED VIA ONSITE OBSERVATION OF THE AIR LEAKAGE. THE UNIT WAS DIAGNOSED AND IT WAS DISCOVERED THAT THE AIR LEAKAGE WAS DUE TO A FAULTY CIRCUIT TUBE. THE PHILIPS ASP REPLACED THE CIRCUIT TUBE TO RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP REPLACED THE CIRCUIT TUBE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547744 ↗
• MalfunctionJun 18, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE TOUCHSCREEN WAS NOT WORKING. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. IT WAS REPORTED THAT THE TOUCHSCREEN WAS NOT WORKING. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547262 ↗
• MalfunctionJun 17, 2026Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A LOW LEAK CO2 REBREATHING RISK ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP) WAS RECEIVED ON 15JUN2026. THE ASP DID NOT PROVIDE THE DEVICE'S DIAGNOSTIC REPORT (DRPT). THE ASP CONFIRMED THAT THE DEVICE HAD NOT YET BEEN CONNECTED TO A PATIENT AT THE TIME OF THE ALARM, AND THAT THERE HAD BEEN NO HARM AS A RESULT OF THE ISSUE. THE ASP CONFIRMED THAT SERVICE HAD BEEN COMPLETED ON THE DEVICE. IT WAS STATED THAT THE PART NUMBERS AND DESCRIPTIONS FOR ANY PARTS USED IN THE SERVICE WERE ASKED BUT UNKNOWN (ASKU). THE ASP WAS ABLE TO CONFIRM THAT THE ISSUE WAS RESOLVED, THE DEVICE WAS FULLY FUNCTIONAL, AND THE HAD BEEN RETURNED TO USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE PRODUCT MALFUNCTIONED WAS CONFIRMED. THE LIKELY CAUSE OF THE DEVICE ISSUE CANNOT BE DETERMINED AS THE PART INFORMATION FOR THE PARTS USED WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535789 ↗
• MalfunctionJun 17, 2026Power Problem

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN AUXILIARY POWER SUPPLY FAILURE ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER STATED THAT WHILE PREPARING TO USE THE VENTILATOR, THE AUXILIARY POWER SUPPLY ALARM OCCURRED, AND THE DEVICE COULD NOT BE SHUT DOWN NORMALLY. A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP) WAS RECEIVED ON 15JUN2026. THE DEVICE'S DIAGNOSTIC REPORT (DRPT) WAS NOT PROVIDED. THE ASP CONFIRMED THAT THE DEVICE HAD NOT YET BEEN CONNECTED TO A PATIENT AT THE TIME OF THE EVENT. THE ASP CONFIRMED THAT SERVICE HAD BEEN COMPLETED ON THE DEVICE BUT STATED THAT THE PART INFORMATION USED IN THE SERVICE WAS ASKED BUT UNKNOWN (ASKU). THE ASP WAS ABLE TO CONFIRM THAT THE ISSUE WAS RESOLVED, WAS FULLY FUNCTIONAL, AND HAD BEEN RETURNED TO USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE PRODUCT MALFUNCTIONED WAS CONFIRMED. THE LIKELY CAUSE OF THE DEVICE ISSUE CANNOT BE DETERMINED AS THE PART INFORMATION FOR THE PARTS U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533828 ↗
• MalfunctionJun 12, 2026Insufficient Flow or Under Infusion

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING A DEVICE MALFUNCTION AS THE TIDAL VOLUME WAS EXCEPTIONALLY LOW. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED AS THE ISSUE OCCURRED DURING A USER CHECK. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE TIDAL VOLUME WAS EXCEPTIONALLY LOW. NO ACCESSORIES WERE USED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486806 ↗
• MalfunctionJun 10, 2026Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN OVER-VOLTAGE PROTECTION (OVP) CIRCUIT FAILED ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. IT WAS REPORTED THAT A PATIENT WAS SUFFERING FROM RESPIRATORY FAILURE AND LOW BLOOD OXYGEN SATURATION, SO THEY REQUIRED VENTILATOR SUPPORT VIA NON-INVASIVE VENTILATION. A NURSE POWERED ON THE DEVICE TO PREPARE THE DEVICE FOR USE, AND IT PRODUCED THE OVP CIRCUIT FAILED ALARM. THE NURSE IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER NON-INVASIVE VENTILATOR. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP), THE ALARM WAS CLARIFIED. THE ASP CONFIRMED THAT SERVICE HAD BEEN COMPLETED ON THE DEVICE BY A THIRD PARTY SERVICE PROVIDER. THE ASP WAS ONLY ABLE TO CONFIRM THAT FOLLOWING THE THIRD PARTY SERVICE, THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY AND WAS ABLE TO RESUME OPERATION. THE SPECIFIC DETAILS OF THE REPAIR WERE NOT PROVIDED BY THE CUSTOMER. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE PRODUCT WAS DETERMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460579 ↗
• MalfunctionJun 10, 2026Tidal Volume Fluctuations

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A LOW TIDAL VOLUME ISSUE. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459292 ↗
• MalfunctionJun 3, 2026Complete Loss of Power

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN OVER-VOLTAGE PROTECTION (OVP) CIRCUIT FAILURE. NO PATIENT OR USER HARM REPORTED. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. A PATIENT WAS ADMITTED WITH A DIAGNOSIS OF ACUTE UPPER RESPIRATORY TRACT INFECTION. THE PATIENT WAS PLACED ON THE VENTILATOR, AND IT INITIALLY OPERATED NORMALLY. HOWEVER, DURING A SUBSEQUENT ROUND BY A NURSE IT WAS DISCOVERED THAT THE DEVICE WAS DISPLAYING THE OVP CIRCUIT FAILURE ALARM. THE PATIENT'S BREATHING RHYTHM WAS OBSERVED TO BE DESYNCHRONIZED WITH THE VENTILATORS AIR DELIVERY RHYTHM. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374445 ↗
• MalfunctionJun 3, 2026Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A LOW LEAK CO2 REBREATHING RISK ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE PATIENT THE DEVICE WAS IN USE ON WAS MOVED TO ANOTHER DEVICE TO CONTINUE MONITORING. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374441 ↗
• MalfunctionMay 29, 2026Unexpected Shutdown

  IT WAS REPORTED THAT WHILE A V60 VENTILATOR WAS IN CLINICAL USE, THE DEVICE EXPERIENCED AN UNEXPECTED SHUTDOWN, RESULTING IN A DEVICE MALFUNCTION. A REMOTE SERVICE ENGINEER (RSE) EVALUATED THE ISSUE AND SUSPECTS THE ROOT CAUSE TO BE A FAILURE WITHIN THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). TO DATE, ONSITE SERVICE AND REPAIR HAVE NOT BEEN COMPLETED DUE TO AN INVALID SERVICE AGREEMENT WITH THE CUSTOMER FACILITY. NO PATIENT OR USER INJURY, HARM, OR ADVERSE CLINICAL OUTCOMES WERE REPORTED. THE INVESTIGATION INTO THIS EVENT IS CURRENTLY ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337187 ↗
• MalfunctionMay 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS LOW AIR PRESSURE WITH AN AIR LEAK. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THERE WAS LOW AIR PRESSURE WITH AN AIR LEAK. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE VIA OBSERVATIONAL INSPECTION. THE PHILIPS ASP CONFIRMED THAT THERE WAS AIR LEAKAGE AT THE CIRCUIT TUBE. THE PHILIPS ASP RAN A V60 TEST AND CONFIRMED THE AIR LEAKAGE AT THE CIRCUIT TUBE. THE PHILIPS ASP REPLACED THE CIRCUIT TUBE TO RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP REPLACED THE CIRCUIT TUBE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317033 ↗
• MalfunctionMay 28, 2026Tidal Volume Fluctuations

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN UNEXPECTED LOW TIDAL VOLUME AND LOW MINUTE VENTILATION ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER STATED THAT THERE WAS NO ADVERSE IMPACT RESULTING FROM THE EVENT, AND THAT THE DEVICE WAS FORWARDED TO THE MEDICAL EQUIPMENT DEPARTMENT OF THE CUSTOMER SITE. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316052 ↗
• MalfunctionMay 26, 2026Tidal Volume Fluctuations; Failure to Deliver

  THE CUSTOMER REPORTED THAT THE V60 VENTILATOR HAD NO AIR INTAKE. THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS OBSERVED. NO PATIENT IMPACT AND/OR HARM WAS REPORTED. NO USER IMPACT AND/OR HARM WAS REPORTED. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278480 ↗
• MalfunctionMay 21, 2026Failure to Deliver

  ON 07MAY2026, PHILIPS RECEIVED INFORMATION FROM THE AFFILIATED HOSPITAL OF GUANGDONG MEDICAL UNIVERSITY STATING THE FOLLOWING: A PATIENT WAS ADMITTED FOR TREATMENT DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH ACUTE EXACERBATION. ON 29APR2026, THE PATIENT'S BLOOD OXYGEN SATURATION WAS 90% (HYPOXEMIA), WHICH WAS BELOW THE NORMAL RANGE. THE NURSES OF THE GERIATRICS DEPARTMENT (INTENSIVE CARE UNIT) USED A NON-INVASIVE VENTILATOR AS PRESCRIBED, STRICTLY FOLLOWING THE DEVICE MANUAL TO IMPROVE THE PATIENT'S OXYGENATION AND INCREASE THE PATIENT'S BLOOD OXYGEN SATURATION TO THE NORMAL RANGE. AFTER THE DEVICE WAS POWERED ON, IT DISPLAYED A "NO OXYGEN SUPPLY" ERROR MESSAGE. THE OPERATOR CHECKED THE OXYGEN SUPPLY UNIT AND OXYGEN CONNECTORS AND CONFIRMED THAT THERE WERE NO ABNORMALITIES. THE DEVICE STILL COULD NOT BE USED NORMALLY. THE DEVICE WAS IN USE ON THE PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. BECAUSE THE DEVICE MALFUNCTION WAS PROMPTLY DETECTED AND STOPPED IN TIME, NO SUBSTANTIAL HARM WAS CAUSED TO THE PATIENT; HOWEVER, THE PATIENT WAS ELDERLY, HIGH-RISK INDIVIDUAL WITH SEVERE UNDERLYING CONDITIONS, AND THERE WAS A HIGH SAFETY RISK DURING THE DEVICE MALFUNCTION. AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242672 ↗
• MalfunctionMay 19, 2026Tidal Volume Fluctuations

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE OBSERVED TIDAL VOLUME VALUE WAS LOWER THAN THE EXPECTED SET VALUE. NO PATIENT OR USER HARM REPORTED. IT IS UNKNOWN IF THE DEVICE WAS IN 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 25219378 ↗
• MalfunctionMay 19, 2026Failure to Sense

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A PRESSURE SENSOR AUTOZERO FAILED ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A PATIENT WAS ADMITTED ON (B)(6) 2026 WITH A DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ACCOMPANIED BY AN ACUTE LOWER RESPIRATORY TRACT INFECTION, AND WITH A HISTORY OF "RECURING COUGHING AND EXPECTORATION ACCOMPANIED BY SHORTNESS OF BREATH FOR OVER 20 YEARS, WITH AN EXACERBATION LASTING MORE THAN HALF A MONTH." ON (B)(6) 2026, FOLLOWING A PHYSICIAN'S ORDERS, THE ASSIGNED NURSE INITIALED USE OF THE NON-INVASIVE VENTILATION SUPPORT WITH A V60 TO TREAT THE TYPE 2 RESPIRATORY FAILURE. PRIOR TO USE ON THE PATIENT, A ROUTINE INSPECTION OF THE NON-INVASIVE VENTILATOR WAS CONDUCTED; THE DEVICE APPEARED PHYSICALLY INTACT, ITS LABELING WAS CLEAR, AND IT REMAINED WITHIN ITS VALID SERVICE LIFE. UPON POWERING ON THE DEVICE, THE SCREEN DISPLAYED A MESSAGE: "VENTILATOR NOT WORKING, 1007: MACHINE AND PROXIMAL PRESSURE SENSOR FAILURE." THE MACHINE THEN ALARMED FOR CHECK VENT: MACHINE PRESSURE SENSOR AUTOZERO FAILED. THE EVENT WAS REPORTED TO THE HEAD NURSE, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217418 ↗
• MalfunctionMay 18, 2026Failure to Power Up

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS DAMAGED AND "BLEW UP." IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE PCBA WAS DAMAGED AND "BLEW UP". PER GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED 15MAY2026, THE UNIT WAS NOT ABLE TO TURN ON DUE TO THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) BEING DAMAGED. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202128 ↗