PHILIPS 1053615Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00884838009868), received between Jan 19, 2017 and May 29, 2026 — classified as 132 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (36 reports).

1 FDA recall record name this device's identifier, 1 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. May 15, 2023Open, Classified

   Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.

   Z-2025-2023 · Root cause: No Marketing Application · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Failure to Run on Battery

  IT WAS REPORTED THAT WHILE A V60 VENTILATOR WAS IN CLINICAL USE, THE DEVICE BACKUP BATTERY BECAME NON-FUNCTIONAL, RESULTING IN A DEVICE MALFUNCTION. A REMOTE SERVICE ENGINEER (RSE) WAS CONTACTED, AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER FACILITY TO INSPECT THE DEVICE. THE FSE REPLACED THE BACKUP BATTERY TO RESOLVE THE ISSUE. FOLLOWING THE COMPONENT REPLACEMENT, THE FSE PERFORMED A PERFORMANCE VERIFICATION TEST (PVT). THE DEVICE SUCCESSFULLY PASSED THE PVT, CONFIRMING A RETURN TO FULL OPERATING FUNCTIONALITY. NO PATIENT OR USER INJURY, HARM, OR ADVERSE CLINICAL OUTCOMES WERE REPORTED. THE INVESTIGATION CONCLUDED THAT THE LIKELY CAUSE OF THE MALFUNCTION WAS A FAILED BACKUP BATTERY. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334735 ↗
• MalfunctionApr 7, 2026Failure to Sense

  PHILIPS RECEIVED A COMPLAINT FROM THE TECHNICIAN, REPORTING THAT THE V60 VENTILATOR DISPLAYED A "PB AUTOZERO OF THE INTERNAL PRESSURE SENSOR" ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE TECHNICIAN NOTED THAT THE V60 VENTILATOR DISPLAYED A "PB AUTOZERO OF THE INTERNAL PRESSURE SENSOR" ERROR CODE, WHILE IN NORMAL VENTILATION MODE. THE TECHNICIAN ALSO REPORTED THAT THE PRESSURE ACCURACY WAS OUT OF RANGE, AS THE MACHINE ZERO OFFSET IS BETWEEN 1 AND -1.5, BUT THE VALUE WAS 1.52. TROUBLESHOOTING WAS PERFORMED, AND IT WAS REPORTED THAT THE MESSAGE DID NOT REAPPEAR AFTER ANOTHER TRY. THE SERVICE ENGINEER (SE) RECOMMENDED CHECKING THE POSITIONING OF THE DATA ACQUISITION (DA) CARD AND CHECKING THE PROXIMAL AND MACHINE TUBING. THE SE ALSO RECOMMENDED REPLACING THE DA CARD. A QUOTE WAS PROVIDED TO THE CUSTOMER. INVESTIGATION ONGOING / RESOLUTION PENDING A REVIEW OF THE RISK MANAGEMENT FILE WAS PERFORMED, AND IT WAS DETERMINED THAT THIS COMPLAINT IS A REPORTABLE MALFUNCTION. REGULATORY REPORTS HAVE BEEN/WILL BE SUBMITTED PER REGULATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806052 ↗
• MalfunctionFeb 11, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE HAS A NAVIGATION RING ASSEMBLY FAILURE. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318010 ↗
• MalfunctionFeb 5, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER INDICATING AN UNSPECIFIED MALFUNCTION, WITH A PART ORDER FOR A V60 DEVICE¿S USER INTERFACE (UI) ASSEMBLY WITH NAV-RING. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. PER THE GOOD FAITH EFFORT (GFE) RESPONSE, THE CUSTOMER REQUESTED A QUOTATION ONLY FOR THE UI ASSEMBLY WITH NAV-RING, AND A QUOTE WAS PROVIDED ACCORDINGLY. NO TECHNICAL INFORMATION REGARDING A DEVICE ISSUE WAS REQUESTED OR AVAILABLE. NO ADDITIONAL INFORMATION CAN BE OBTAINED. THIS CASE WAS CONFIRMED TO BE PARTS-QUOTE ONLY, REQUIRES NO FURTHER SUPPORT, AND HAS BEEN CLOSED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT FILE WILL BE REOPENED AS APPROPRIATE, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273074 ↗
• MalfunctionDec 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS FOUND TO BE DEFECTIVE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ONSITE TO EVALUATE AND REPAIR THE DEVICE. UPON ARRIVAL, THE FSE REPLACED THE USER INTERFACE (UI) ASSEMBLY, AFTER WHICH THE ISSUE WAS RESOLVED. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899060 ↗
• MalfunctionDec 4, 2025Tidal Volume Fluctuations; Tidal Volume Fluctuations

  PHILIPS RECEIVED A CUSTOMER COMPLAINT REGARDING THE V60, INDICATING THAT THE DEVICE DISPLAYED AN INCORRECT TIDAL VOLUME MEASUREMENT. THREE FAULTY COMPONENTS WERE IDENTIFIED IN THE DEVICE. IT WAS REPORTED THAT NO PATIENT WAS CONNECTED TO OR IMPACTED BY THE DEVICE AT THE TIME THE ISSUE WAS DISCOVERED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717707 ↗
• MalfunctionDec 3, 2025Inadequate User Interface; Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE TOUCHSCREEN WAS NOT CORRECTLY RESPONDING TO TOUCH INPUTS. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A REMOTE SERVICE ENGINEER (RSE) WAS INFORMED BY THE CUSTOMER OF THE TOUCHSCREEN ISSUE. THE CUSTOMER STATED THAT THE TOUCHSCREEN FUNCTION WOULD WORK INTERMITTENTLY. A TOUCHSCREEN CALIBRATION WAS COMPLETED, BUT THE ISSUE PERSISTED. THE RSE DETERMINED THAT THE TOUCHSCREEN WOULD NEED TO BE REPLACED. A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND REPLACED THE TOUCHSCREEN. THE FSE THEN COMPLETED A TOUCHSCREEN CALIBRATION AND PERFORMANCE VERIFICATION TEST (PVT), WHICH THE DEVICE PASSED. HAVING CONFIRMED THE FULL FUNCTIONALITY OF THE DEVICE, IT WAS PROVIDED BACK TO THE CUSTOMER READY FOR USE. 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 23706017 ↗
• MalfunctionAug 8, 2025Display Difficult to Read; Display Difficult to Read

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THAT DEVICE¿S SCREEN LOOKS VERY DARK AND NEEDS TO BE REPLACED. THE DEVICE WAS IN NORMAL 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. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THAT THE SCREEN LOOKS VERY DARK AND DOESN'T IMPROVE BY INCREASING THE BRIGHTNESS. THE CUSTOMER RECEIVED THE REPLACEMENT DISPLAY. HOWEVER, THE UNIT HAS AN OLD MODEL OF THE DISPLAY, AND OTHER PARTS ARE NEEDED TO BE ABLE TO INSTALL THE NEW MODEL. ADDITIONAL REQUIRED PARTS WERE ORDERED TO CONTINUE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755703 ↗
• MalfunctionJul 23, 2025Mechanical Problem; Mechanical Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE OXYGEN (O2) HOSE CANNOT BE ATTACHED CORRECTLY TO THE PNEUMOLOGY WALL OXYGEN SOURCE. AT THIS TIME, IT IS UNKNOWN WHETHER 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 HOOKS ARE PROBABLY DAMAGED BECAUSE THEY CAN'T ATTACH THE O2 HOSE CORRECTLY TO THE PNEUMOLOGY WALL OXYGEN SOURCE. THE REMOTE SERVICE ENGINEER (RSE) EVALUATED THE DEVICE WITH THE CUSTOMER AND FOUND THAT THE REPLACEMENT OXYGEN (O2) HOSE NEEDED TO BE ORDERED FOR REPAIR. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580020 ↗
• MalfunctionJul 18, 2025Failure to Deliver; Failure to Deliver

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DEVICE IS GETTING AN ERROR OXYGEN DISCONNECTED EVEN THOUGH IT IS CONNECTED. 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. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE RSE INSTRUCTED THE CUSTOMER TO RUN SOME TESTS TO VERIFY THAT THE OXYGEN CONNECTIONS WERE PROPERLY TIGHTENED. AFTER THE CUSTOMER PERFORMED THE SUGGESTED TESTS AND ADJUSTED CONNECTIONS, THE CUSTOMER INFORMED THAT IT RESOLVED THE REPORTED ISSUE. THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545691 ↗
• MalfunctionJul 15, 2025Inadequate User Interface; Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE¿S NAVIGATION RING IS NOT WORKING ANYMORE. A REPLACEMENT IS REQUIRED. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509814 ↗
• MalfunctionJun 2, 2025Unstable; Device Fell; Unstable; Device Fell

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DEVICE FELL. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE DEVICE FELL. THE CUSTOMER REPORTED THAT THE END CAP WAS MISSING AFTER THE FALL. THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE END CAP FOR THE CUSTOMER TO ORDER AND REPLACE. DEVICE EVALUATION AND REPAIR ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124486 ↗
• MalfunctionMay 12, 2025Computer Software Problem; Computer Software Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE IS GETTING ALARM 110F POSTO2FLOWSENSORCALERROR MESSAGE. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006250 ↗
• MalfunctionMay 6, 2025Mechanical Problem; Mechanical Problem

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS 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 THERE WAS A BLOWER ASSEMBLY FAILURE. A REPAIR QUOTE FOR THE REPLACEMENT BLOWER ASSEMBLY WAS SENT TO THE CUSTOMER FOR APPROVAL, AND THE CUSTOMER ACCEPTED. THE REPLACEMENT BLOWER ASSEMBLY HAS BEEN SHIPPED TO THE CUSTOMER FOR REPAIR. INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969009 ↗
• MalfunctionApr 24, 2025Grounding Malfunction; Grounding Malfunction

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE ELECTRICAL SAFETY TEST FAILED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE ELECTRICAL SAFETY TEST FAILED. ONSITE SERVICE WAS REQUESTED BUT LATER CANCELLED. NO FURTHER SERVICE PROVIDED. ONSITE SERVICE CANCELLED. 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 21901626 ↗
• MalfunctionApr 24, 2025Grounding Malfunction; Grounding Malfunction

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE (PM) TEST AND VERIFICATION, THE DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE OCCURRED. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900147 ↗
• MalfunctionApr 2, 2025Failure to Charge; Failure to Charge

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE BATTERY WAS NOT HOLDING THE CHARGE, AND THE DEVICE WAS NOT OPERATING IN BATTERY MODE. 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 NOT HOLDING THE CHARGE, AND THE DEVICE COULD NOT OPERATE IN BATTERY MODE. A SERVICE QUOTE FOR REPAIR WAS SENT TO THE CUSTOMER FOR APPROVAL. INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756425 ↗
• MalfunctionApr 1, 2025Unintended Power Up; Unintended Power Up

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DOES NOT TURN OFF. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR DOES NOT TURN OFF. A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AND REPORTED THAT THE POWER SUPPLY AND POWER MANAGEMENT BOARD WERE REPLACED. THE SE REPORTED THAT ADDITIONAL REPAIRS WERE REQUIRED, AS THE DEVICE CONTINUES TO TURN ON AND OFF BY ITSELF. IT WAS NOTED THAT A REPLACEMENT USER INTERFACE ASSEMBLY WAS ORDERED. INVESTIGATION ONGOING / RESOLUTION PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742946 ↗
• MalfunctionMar 12, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT WITH MANUFACTURER IS BEING SUBMITTED AS A CORRECTION TO REPLACE MANUFACTURER REPORT. FDA REQUESTED THE SUBMISSION OF A MISSING FOLLOW UP. UPON REVIEW, IT WAS DETERMINED THAT THE MANUFACTURER SITE NUMBER IS INCORRECT RESULTING IN INCORRECT REPORT NUMBER. THE CUSTOMER REPORTED THE VENTILATOR IS GIVING OXYGEN VALUE ISSUES. THE CUSTOMER STATED THAT THE VENTILATOR WAS DISPLAYING ERRONEOUS OXYGEN VALUES, AND A LEAK WAS SUSPECTED. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED PROBLEM. THE FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE AND WAS ABLE TO DUPLICATE THE REPORTED PROBLEM AND REPLACED THE O2 SOLENOID VALVE AS A REPAIR ACTION. AFTER ALL THE REPAIRS WERE COMPLETED, THE DEVICE PASSED ITS PERFORMANCE TESTS. THE O2 SOLENOID VALVE WAS RETURNED TO THE FACTORY FOR FURTHER ANALYSIS. AT THE FACTORY, THE VALVE WAS THOROUGHLY TESTED, AND THE CUSTOMER'S ISSUE WAS REPLICATED. AN EVALUATION OF THE SOLENOID VALVE FOUND DEBRIS PARTICULATES THAT PREVENTED THE VALVE FROM CLOSING PROPERLY AND ALLOWING FOR O2 TO LEAK. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT WAS DETERMINED TO BE A MALFUNCTIONING OXYGEN SOLENOID VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584608 ↗
• MalfunctionMar 11, 2025Failure to Charge; Failure to Run on Battery; Failure to Charge; Failure to Run on Battery

  PHILIPS RECEIVED A COMPLAINT FROM THE SERVICE ENGINEER (SE), REPORTING THAT THE V60 VENTILATOR HAD A BATTERY THAT WAS NON-FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS SERVICE ENGINEER (SE) REPORTED THAT THE V60 VENTILATOR HAD A BATTERY THAT WAS NON-FUNCTIONAL. THE SE NOTED THAT THE BATTERY WOULD NEED TO BE REPLACED. INVESTIGATION ONGOING / RESOLUTION PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575296 ↗
• MalfunctionFeb 26, 2025Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE ALARMS DO NOT FUNCTION. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472817 ↗
• MalfunctionFeb 10, 2025No Display/Image; No Display/Image

  PHILIPS RECEIVED A COMPLAINT BY THE MECHANICAL ENGINEER (ME) ON THE V60 INDICATING DURING PERIODICAL DEVICE CHECKING, IT WAS OBSERVED THAT THE SCREEN BRIGHTNESS WAS DIM EVEN WHEN IT WAS SET AT 5. THE DEVICE KEPT OPERATING WHEN THE ISSUE WAS OBSERVED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. INVESTIGATION ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349406 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A COOLING FAN FAILURE. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298284 ↗
• MalfunctionJan 27, 2025Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS A CONTINUOUS ALARM THAT HAD OCCURRED. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241087 ↗
• MalfunctionDec 4, 2024Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ABOUT THE V60 VENTILATOR INDICATING THAT THE FLOW SENSOR WAS OUT OF RANGE. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. THERE WAS NO PATIENT OR USER HARM REPORTED. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE FIELD SERVICE ENGINEER (FSE), IT WAS STATED THAT THE FLOW SENSOR ASSEMBLY (FSA) HAD BEEN REPLACED FROM LOCAL STOCK AT THE CUSTOMER SITE. FOLLOW-UP GFES WERE COMPLETED TO OBTAIN CLARIFICATION ON THE DEVICE ISSUE WHICH LED TO THE NEED FOR FSA REPLACEMENT. THE FSE PROVIDED THAT THE AIR FLOW SENSOR WAS OUT OF THE ALLOWABLE RANGE. WHEN ASKED WHAT PERFORMANCE VERIFICATION TEST (PVT) FAILED, THE FSE STATED THAT THE ISSUE WAS NOT FOUND DURING A PVT. DUE TO THIS, THE ISSUE IS CONSIDERED AN OUTPUT FLOW ERROR. THE REPLACED FSA WAS CONFIRMED BY THE FSE TO HAVE RESOLVED THE OUTPUT FLOW ERROR, AND THE DEVICE PASSED A PVT. THE DEVICE WAS CONFIRMED TO HAVE BEEN RETURNED TO USE. THE FSE INDICATED THAT THE REPLACED FSA WILL NOT BE RETURNED TO PHILIPS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847281 ↗