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PHILIPS 1053613Recalls & reported problems

Respironics California, Inc. · V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Philips ventilator supports breathing for patients. Of the 160 reports, 158 are malfunctions, many describing battery and charging failures or frozen screens. The reports include 1 death and 1 injury, and reports fell to 19 in the last 12 months from 32 before. There are 2 open recalls: one for an electrical circuit that can stop the ventilator, and one for a pressure limit in High Flow software.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
161
Deaths reported
1
Injuries reported
1
Recalls naming it
2

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00884838009844), received between Feb 17, 2017 and Sep 29, 2026 — classified as 1 death, 1 injury, 159 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (30 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 1 reportsApr 2024: 3 reportsMay 2024: 1 reportsJun 2024: 5 reportsJul 2024: 2 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 2 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 3 reportsFeb 2025: 0 reportsMar 2025: 4 reportsApr 2025: 7 reportsMay 2025: 11 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 6 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 3 reportsMar 2026: 2 reportsApr 2026: 2 reportsMay 2026: 1 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202611
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Battery Problem30
  • Inadequate User Interface28
  • Failure to Charge20
  • Failure to Run on Battery11
  • Defective Alarm5
  • Device Sensing Problem5
  • Power Problem5
  • Failure to Power Up4

Patient problems

  • No Clinical Signs, Symptoms or Conditions141
  • Insufficient Information11
  • No Known Impact Or Consequence To Patient7
  • No Patient Involvement6
  • Hypoxia1
  • Unspecified Respiratory Problem1

Recent adverse event reports

The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Inadequate User Interface

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50931546 ↗
  • MalfunctionJul 27, 2026Tidal Volume Fluctuations

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50007769 ↗
  • MalfunctionJun 2, 2026Unstable

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE'S FEET WERE BROKEN AND COULD NOT BE ANCHORED TO SECURE THE DEVICE TO THE CART. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE ISSUE WAS OBSERVED BY A FIELD SERVICE ENGINEER (FSE) WHEN THEY WERE AT THE CUSTOMER SITE SERVICING THE DEVICE. THE FSE DETERMINED THAT THE BOTTOM FOOT KIT NEEDED TO BE REPLACED. THE CUSTOMER WAS PROVIDED WITH A QUOTE FOR THE REPLACEMENT PART. THIS INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25363215 ↗
  • MalfunctionMay 21, 2026Failure to Charge

    CUSTOMER BIOMED REPORTED A V60 VENTILATOR THAT EXPERIENCED AN INTERNAL BATTERY CHARGE FAILURE DURING CORRECTIVE MAINTENANCE ACTIVITIES. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME, AND NO PATIENT INVOLVEMENT, USER HARM, OR INJURIES WERE REPORTED. THE ISSUE RESULTED IN THE TEMPORARY UNAVAILABILITY OF THE DEVICE UNTIL CORRECTIVE ACTION COULD BE COMPLETED. A REMOTE SERVICE ENGINEER (RSE) ASSISTED THE CUSTOMER IN CONFIRMING THE PROBLEM, AND A REVIEW OF THE DIAGNOSTIC REPORT (DRPT) VERIFIED THE INTERNAL BATTERY CHARGE FAILURE CONDITION, NOTING THAT THE BATTERY CHARGE INDICATOR WAS FLASHING A "FAIL" STATUS. CORRECTIVE MAINTENANCE ACTIONS WERE INITIATED TO REPLACE THE FAILED INTERNAL BATTERY, AND THE FINAL DISPOSITION OF THE DEVICE REMAINS PENDING UNTIL THE REPLACEMENT AND ASSOCIATED SERVICE ACTIVITIES ARE COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25246585 ↗
  • MalfunctionApr 15, 2026Unexpected Shutdown

    PHILIPS TECHNICAL SUPPORT RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DEVICE TURNED ON AND OFF BY ITSELF. 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. ADDITIONAL INFORMATION IS BEING GATHERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24884782 ↗
  • MalfunctionApr 2, 2026Failure to Run on Battery

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A BATTERY FAILURE 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 BATTERY FAILURE OCCURRED. THIS INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24765640 ↗
  • MalfunctionMar 17, 2026Failure to Sense

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT A 110B "PROXIMAL PRESSURE SENSOR AUTOZERO FAILED" ALARM ERROR OCCURRED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND FOUND THAT THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND SOLENOID VALVE MAY NEED TO BE REPLACED. THE RSE RECOMMENDED REPLACING THE SOLENOID VALVE, AND IF THE ISSUE PERSISTED, THE RSE ALSO SUGGESTED REPLACING THE DA PCBA. A SERVICE QUOTE CONSISTING OF THE REPLACEMENT DA PCBA AND SOLENOID VALVE WAS SENT TO THE CUSTOMER FOR APPROVAL, AND THE CUSTOMER ACCEPTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24622088 ↗
  • MalfunctionMar 13, 2026Failure to Run on Battery

    PHILIPS RECEIVED A COMPLAINT BY THE AUTHORIZED SERVICE PROVIDER (ASP) ON THE V60 INDICATING THAT A 1124 "BATTERY FAILED" ALARM ERROR OCCURRED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE, FOUND THAT A 1124 "BATTERY FAILED" ALARM ERROR WAS LOGGED IN THE EVENT LOG, AND DISCOVERED THAT THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) NEEDED TO BE REPLACED FOR REPAIR. A QUOTE CONSISTING OF THE REPLACEMENT PM PCBA WAS SENT TO THE CUSTOMER FOR APPROVAL. RESOLUTION AND DISPOSITION:

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24595106 ↗
  • MalfunctionFeb 25, 2026Device Sensing Problem

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT A 1009 "PRESSURE REGULATION HIGH" ERROR OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORT OF PATIENT OR USER HARM. IN ACCORDANCE WITH THE V60 SERVICE MANUAL, THE CUSTOMER FOUND THAT THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY AND MOTOR CONTROLLER (MC) PCBA NEEDED TO BE REPLACED AFTER CHECKING THE PNEUMATIC CIRCUIT. A QUOTE CONSISTING OF THE REPLACEMENT PARTS WAS SENT TO THE CUSTOMER FOR APPROVAL. REPAIR OF THE DEVICE IS CURRENTLY PENDING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24447077 ↗
  • MalfunctionFeb 10, 2026Inadequate User Interface

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE HAD A TOUCHSCREEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24306583 ↗
  • MalfunctionFeb 6, 2026Device Alarm System

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT A 1104 "BACKUP ALARM FAILED" ALARM ERROR OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. A SERVICE QUOTE WAS SENT TO THE CUSTOMER FOR APPROVAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24278716 ↗
  • MalfunctionDec 26, 2025Inadequate User Interface; Inadequate User Interface

    PHILIPS RECEIVED A COMPLAINT ABOUT THE V60 VENTILATOR INDICATING THAT THE DISPLAY WAS FREEZING. DUE TO THE DISPLAY FREEZING, IT WAS STATED THAT THE DEVICE COULD NOT BE OPERATED. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. THERE WAS NO PATIENT OR USER HARM REPORTED. THE CUSTOMER WAS PROVIDED WITH A QUOTE FOR A REPLACEMENT FRONT BEZEL WITH NAVIGATION RING (NAV-RING) AND BENCH SERVICE, WHICH WAS ACCEPTED. THE INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23896091 ↗
  • MalfunctionDec 10, 2025Grounding Malfunction; Grounding Malfunction

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE POWER CORD DID NOT PASS THE ELECTRICAL SAFETY TEST. 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) PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE POWER CORD TO ORDER AND REPLACE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23769625 ↗
  • MalfunctionDec 4, 2025Battery Problem: Low Impedance; Battery Problem: Low Impedance

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE BATTERY WAS DEPLETED. AT THIS TIME, IT IS 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 THE BATTERY WAS DEPLETED. A SERVICE QUOTE CONSISTING OF THE REPLACEMENT BATTERY WAS SENT TO THE CUSTOMER FOR APPROVAL, AND THE CUSTOMER ACCEPTED. INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23719932 ↗
  • MalfunctionNov 25, 2025Grounding Malfunction; Grounding Malfunction

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR REPORTING THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE (PM), IT WAS DISCOVERED THAT THE DEVICE'S POWER CABLE NEEDS REPLACED. ITS GROUND RESISTANCE IS 0.6 OHM, WHEN IT SHOULD BE NO MORE THAN 0.2 OHM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23649404 ↗
  • MalfunctionNov 25, 2025Failure to Charge; Failure to Charge

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR REPORTING THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE (PM), IT WAS DISCOVERED THAT THE DEVICE HAS A FAULTY BATTERY. THE BATTERY DOES NOT CHARGE. THE DEVICE OPERATES ONLY FROM A 220V NETWORK, WHICH CREATES A SAFETY ISSUE FOR A PATIENT IN THE EVENT OF A POWER FAILURE. THE FAULTY BATTERY REQUIRES REPLACEMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23649264 ↗
  • MalfunctionNov 25, 2025Failure to Deliver; Failure to Deliver

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING WHILE PERFORMING PREVENTATIVE MAINTENANCE (PM), IT WAS OBSERVED THAT THE DEVICE WAS GETTING ERROR CODE 1111 CHECK VENT: OXYGEN DEVICE FAILED MESSAGE, NO MEASUREMENT OF OXYGEN O2. 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. ACCORDING TO THE MAINTENANCE FINDINGS, THE DEVICE WAS OBSERVED TO HAVE NO OXYGEN MEASUREMENT, AND THE SYSTEM DISPLAYED O2 ERROR 1111. THIS INDICATES A FAILURE WITHIN THE OXYGEN SENSING OR DELIVERY MEASUREMENT PATHWAY THAT REQUIRES FURTHER DIAGNOSTIC EVALUATION. DIAGNOSTICS MUST BE PERFORMED USING THE FOLLOWING TEST PARTS TO DETERMINE THE SOURCE OF THE MALFUNCTION USING SPECIFIC TEST PARTS. THE RSE INFORMED CUSTOMER THAT THE COMPONENTS ARE REQUIRED STRICTLY FOR DIAGNOSTIC TESTING AND MUST NOT BE UNPACKED UNTIL THE MALFUNCTION IS FULLY ASSESSED. THE RSE PROVIDED THE CUSTOMER WITH ADDITIONAL TROUBLESHOOTING STEPS FOR THE REPAIR PER PHILIPS SERVICE MANUAL. THIS INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23645605 ↗
  • MalfunctionNov 21, 2025Failure to Charge; Failure to Charge

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THAT THE BATTERY NEEDED TO BE REPLACED AS THE DEVICE WAS NOT HOLDING A CHARGE DURING USE. 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. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE BATTERY NEEDED TO BE REPLACED AS THE DEVICE WAS NOT HOLDING A CHARGE DURING USE. A SERVICE QUOTE CONSISTING OF THE REPLACEMENT BATTERY WAS SENT TO THE CUSTOMER FOR APPROVAL, AND THE CUSTOMER ACCEPTED. THE INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23619573 ↗
  • MalfunctionNov 13, 2025Grounding Malfunction; Grounding Malfunction

    PHILIPS RECEIVED A COMPLAINT BY THE FIELD SERVICE ENGINEER (FSE) CONCERNING A V60 DEVICE. DURING PREVENTIVE MAINTENANCE (PM) TESTING, IT WAS OBSERVED THAT THE DEVICE FAILED THE ELECTRICAL SAFETY TEST DUE TO THE GROUND RESISTANCE MEASURING GREATER THAN 0.2 OHMS. IT WAS REPORTED THAT NO PATIENT WAS INVOLVED AT THE TIME THE ISSUE WAS IDENTIFIED. THE SERVICE ENGINEER PERFORMED TESTING IN ACCORDANCE WITH THE MANUFACTURER¿S RECOMMENDATIONS. AS PER THE GUIDELINES, IT WAS RECOMMENDED TO REPLACE THE POWER CORD IF THE GROUND RESISTANCE EXCEEDED 0.2 OHMS. ACCORDINGLY, THE POWER CORD WAS ORDERED AND REPLACED. FOLLOWING REPLACEMENT, THE DEVICE WAS TESTED AND CONFIRMED TO BE FUNCTIONING PROPERLY, AFTER WHICH IT WAS RETURNED TO THE USER IN WORKING CONDITION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER REVIEW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23547458 ↗
  • MalfunctionNov 13, 2025Inadequate User Interface; Inadequate User Interface

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT DEVICE HAD A TOUCHSCREEN FAILURE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. NO MEDICAL INTERVENTION PROVIDED TO THE PATIENT, NOR A DELAY WAS NOTED. THIS INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23546884 ↗
  • MalfunctionSep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DID NOT WORK (ISSUE NOT SPECIFIED). THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THIS INVESTIGATION IS ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22964063 ↗
  • MalfunctionAug 28, 2025Obstruction of Flow; Obstruction of Flow

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE FLOW SENSOR WAS OUT OF TOLERANCE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE FLOW SENSOR WAS OUT OF TOLERANCE. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE AND REPLACED THE FLOW SENSOR TO RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP REPLACED THE FLOW SENSOR ASSEMBLY 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 22915819 ↗
  • MalfunctionAug 8, 2025Inadequate User Interface; Inadequate User Interface

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT DEVICE HAS TOUCHSCREEN FAILURE. 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. SENT CUSTOMER QUOTE FOR REPAIR. INVESTIGATION ONGOING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22755419 ↗
  • MalfunctionJul 28, 2025Inadequate User Interface; Inadequate User Interface

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT TOUCHSCREEN IS FAULTY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE TOUCHSCREEN IS OUT OF CALIBRATION. THE RSE SENT THE TOUCH CALIBRATION PROCEDURE TO THE CUSTOMER. THE CUSTOMER CALIBRATED THE TOUCHSCREEN BUT WAS STILL UNABLE TO ADJUST THE SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION). FURTHER TROUBLESHOOTING IS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22637483 ↗
  • MalfunctionJul 24, 2025Failure to Run on Battery; Failure to Run on Battery

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR'S BATTERY VOLTAGE FAILED, AND THE DEVICE FAILED TO POWER ON CORRECTLY. 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 V60 VENTILATOR'S BATTERY FAILURE CAUSED THE DEVICE TO FAIL TO POWER ON CORRECTLY. THE CUSTOMER ORDERED A REPLACEMENT BATTERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22593746 ↗

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Sources and updates

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