PHILIPS 1076709Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,174 adverse event reports that list this exact device (DI 00884838033832), received between Nov 14, 2016 and Sep 29, 2026 — classified as 8 deaths, 16 injuries, 2,150 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (680 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934805 ↗
• MalfunctionJul 7, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY A FIELD SERVICE TECHNICIAN ON THE V60 INDICATING A DEVICE MALFUNCTION AS THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. A FIELD SERVICE TECHNICIAN PERFORMED REGULAR MAINTENANCE ON THE DEVICE AND CONFIRMED THAT THERE WAS A TOUCHSCREEN MISALIGNMENT--THE FIELD SERVICE TECHNICIAN CALIBRATED THE TOUCHSCREEN, BUT THE ISSUE REMAINED. THEREFORE, THE FIELD SERVICE TECHNICIAN ULTIMATELY REPLACED THE TOUCHSCREEN, AFTER WHICH THE ISSUE WAS RESOLVED. THE TOUCHSCREEN REPLACEMENT INDICATES THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY TOUCHSCREEN THAT NEEDED TO BE REPLACED FOR REPAIR. FOLLOWING THE TOUCHSCREEN REPLACEMENT, THE FIELD SERVICE TECHNICIAN CONFIRMED THAT SOFTWARE VERSION 3.20 WAS INSTALLED, CONDUCTED A COMPREHENSIVE INSPECTION, CLEANED THE DEVICE, PERFORMED RUNNING AND FUNCTIONAL TESTING, AND RETURNED THE DEVICE TO SERVICE AS THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25734751 ↗
• MalfunctionJul 1, 2026Inadequate User Interface

  WHILE SERVICING THE DEVICE, THE SE REPORTED THAT THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. A TOUCHSCREEN CALIBRATION WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT IMPACT AND/OR HARM WAS REPORTED. THE SE REPLACED THE TOUCHSCREEN TO RESOLVE THE ISSUE. THE DEVICE WAS CHECKED, CLEANED, AND TESTED; THE DEVICE WAS THEN RETURNED TO THE CUSTOMER, READY FOR 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 25679060 ↗
• MalfunctionJun 29, 2026Failure to Deliver

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN OXYGEN NOT AVAILABLE ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE ISSUE OCCURRED DURING A PRE-USE INSPECTION. THE DEVICE OTHERWISE CONTINUED TO OPERATE. AN AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE AT THE REPAIR CENTER. THE DEVICE WAS STARTED WITHOUT CONNECTING THE DEVICE TO HIGH-PRESSURE OXYGEN, SETTING OXYGEN CONCENTRATION TO 100%, AND CONFIRMED THAT AN "OXYGEN UNAVAILABLE" ALARM WAS TRIGGERED AS EXPECTED. THE ASP CONTACTED THE LOCAL BRANCH REPRESENTATIVE WHO LEARNED THAT WHEN THE DEVICE WAS CHECKED PRIOR TO DISPATCH, SIMILARLY, STARTING WITHOUT HIGH-PRESSURE OXYGEN CONNECTED WHILE SET TO 100% OXYGEN CONCENTRATION, THAT AN "OXYGEN UNAVAILABLE" ALARM OCCURRED AS EXPECTED. BASED ON THE AVAILABLE INFORMATION, THE ASP DETERMINED THAT THE DEVICE WAS OPERATING NORMALLY. THE ASP COMPLETED A CLEANING, RUNNING TEST, AND FUNCTION TEST. 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 25652808 ↗
• MalfunctionJun 29, 2026Failure to Deliver

  THE SALES OFFICE STAFF REPORTED THAT THE V60 VENTILATOR DISPLAYED AN "OXYGEN NOT AVAILABLE" ALARM. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO USER IMPACT AND/OR HARM WAS REPORTED. THE SE DETERMINED THAT WHILE THE ALARM WAS CONFIRMED DURING THE EVALUATION OF DEVICE. THERE WAS NO MALFUNCTION OF THE DEVICE, AND THE ALARM WAS EXPECTED TO OCCUR WHEN THE DEVICE'S OXYGEN CONCENTRATION SETTING IS SET TO 100%, WITHOUT THE HIGH-PRESSURE OXYGEN BEING CONNECTED. THE SE REPORTED THAT NO ABNORMALITIES WERE OBSERVED; THE DEVICE WAS CLEANED AND TESTED AND THEN RETURNED TO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651472 ↗
• MalfunctionJun 26, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY A FIELD SERVICE TECHNICIAN ON THE V60 INDICATING A DEVICE MALFUNCTION AS THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. A FIELD SERVICE TECHNICIAN PERFORMED REGULAR MAINTENANCE ON THE DEVICE AND CONFIRMED THAT THE TOUCHSCREEN WAS NOT WORKING AS THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. THE FIELD SERVICE TECHNICIAN PERFORMED TOUCHSCREEN CALIBRATION, BUT THE ISSUE REMAINED. THEREFORE, THE FIELD SERVICE TECHNICIAN ULTIMATELY REPLACED THE TOUCHSCREEN, AFTER WHICH THE ISSUE WAS RESOLVED. THE TOUCHSCREEN REPLACEMENT INDICATES THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY TOUCHSCREEN THAT NEEDED TO BE REPLACED FOR REPAIR. FOLLOWING THE TOUCHSCREEN REPLACEMENT, THE FIELD SERVICE TECHNICIAN CONFIRMED THAT THE SOFTWARE VERSION WAS 3.20, CONDUCTED A COMPREHENSIVE INSPECTION OF THE DEVICE, CLEANED THE DEVICE, PERFORMED RUNNING AND FUNCTIONAL TESTS, AND 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 ACTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640541 ↗
• MalfunctionJun 26, 2026No Display/Image

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DISPLAY WAS DARK. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE DISPLAY WAS DARK. IT WAS ALSO STATED THAT ONLY THE ALARM LIGHT EMITTING DIODE (LED) WAS LIT EVEN AFTER THE UNIT AS POWERED ON DURING IN AN INSPECTION. IT WAS SUSPECTED THAT THE CAUSE OF THE ISSUE WAS DUE TO THE HOSPITAL'S OUTLET DUE TO THE DEVICE BEING ABLE TO BE USED IN OTHER ROOMS. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635636 ↗
• MalfunctionJun 24, 2026Inadequate User Interface

  THE SERIVCE ENGINEER (SE) REPORTED THAT THE V60 VENTILATOR HAD AN ENTER BUTTON THAT WAS NOT RESPONDING. 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. NO TESTING WAS REPORTED TO HAVE BEEN PERFORMED TO DETERMINE THE CAUSE OF THE MALFUNCTION. THE SE WAS SERVICING THE DEVICE WHEN THE ISSUE WAS OBSERVED. THE ISSUE WAS REPLICATED/CONFIRMED DURING SERVICE. THE SE REPLACED THE USER INTERFACE (UI) BOARD ASSEMBLY TO RESOLVE THE ISSUE. NO OTHER ABNORMALITIES WERE FOUND. THE DEVICE WAS RETURNED TO THE CUSTOMER, READY FOR 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 SE REPLACED THE UI BOARD ASSEMBLY TO RESOLVE THE ISSUE. IT IS SUSPECTED THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAILURE IN THE UI ASSEMBLY. 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 THE INVESTIGATION WILL BE UPDATED. BASED ON THE DETAILS PROVIDED, A M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612361 ↗
• MalfunctionJun 18, 2026Device Sensing Problem

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING A DEVICE MALFUNCTION AS A "CHECK VENT: PROXIMAL PRESSURE SENSOR RANGE ERROR" ALARM ERROR OCCURRED. 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 DEVICE KEPT OPERATING WHEN THE ISSUE OCCURRED BUT WAS ULTIMATELY REPLACED WITH THE SAME MODEL. NO REPRODUCIBILITY OF THE ISSUE WAS OBSERVED WHILE RUNNING THE DEVICE AFTER THE SWAP. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548243 ↗
• MalfunctionJun 17, 2026Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE UNIT SUDDENLY SHUT DOWN WHEN THE FIO2 WAS SET FROM 35% TO 40%. 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. THE DEVICE WAS SWAPPED OUT WITH A DIFFERENT DEVICE. NO MEDICAL INTERVENTION PROVIDED TO THE PATIENT NOR A DELAY WAS NOTED. IT WAS REPORTED THAT THE UNIT SUDDENLY SHUT DOWN WHEN THE FIO2 WAS SET FROM 35% TO 40%. IT WAS ALSO REPORTED THAT A "CHECK VENT: VENTILATOR RESTARTED" APPEARED ON THE DEVICE AND THE DEVICE RESTARTED DURING USE ON A PATIENT. NO ALARMS HAD OCCURRED AFTER THE RESTART. THE UNIT WAS SENT TO THE REPAIR CENTER. AT THE REPAIR CENTER, THE REPORTED ISSUE WAS NOT REPRODUCED. THE EVENT LOG WAS CHECKED, AND IT WAS CONFIRMED THAT THE HISTORY OF "CHECK VENT: VENTILATOR RESTARTED." (DIAGNOSTIC CODE 1101) AND "USER INTERFACE CPP." (DIAGNOSTIC CODE 3007) HAD OCCURRED TOGETHER. IT WAS THEN STATED THAT IF BOTH ERROR CODES HAD OCCURRED TOGETHER THEN NO FURTHER ACTION IS REQUIRED. THE DEVICE RESTARTED TO RESOLVE THE CONDITION. THE OCCURRENCE OF "CHECK VENT: VENTILATOR RESTARTED." (DIAGNOSTIC CODE 1101) AND "USER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535380 ↗
• MalfunctionJun 17, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE NAV-RING OPERATED UNINTENTIONALLY. 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 THE CUSTOMER DURING A PERIODICAL CHECK, AND IT WAS REQUESTED THAT SERVICE BE COMPLETED AT A REPAIR CENTER. A SALES REPRESENTATIVE RETRIEVED THE DEVICE FROM THE CUSTOMER SITE. AN AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE AT A REPAIR CENTER AND CONFIRMED THE REPORTED NAV-RING ISSUE. THE ASP FOUND THAT THAT THE DEVICE DID ACCEPT AND CHANGE JUMPING VALUES WITHOUT PRESSING A BUTTON, IT WAS POSSIBLE TO ADJUST VALUES, CONFIRM, CANCEL, ETC. USING THE TOUCHSCREEN, AND THE DEVICE PRESCRIPTION DID NOT CHANGE AUTOMATICALLY WITHOUT USER INPUT. TO RESOLVE THE NAV-RING ISSUE, THE ASP REPLACED THE FRONT BEZEL W/ NAV-RING. 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 25534739 ↗
• MalfunctionJun 16, 2026Complete Blockage

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING A DEVICE MALFUNCTION AS "OXYGEN NOT AVAILABLE" AND "LOW O2 SUPPLY PRESSURE" ALARM ERRORS OCCURRED. 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 DEVICE KEPT OPERATING, BUT THERE WAS NO REPORTED DELAY IN THERAPY OR MEDICAL INTERVENTION. THE SALES REPRESENTATIVE (REP) VISITED THE HOSPITAL AND REPLACED THE DEVICE WITH A TRILOGYO2 VENTILATOR. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT "OXYGEN NOT AVAILABLE" AND "LOW O2 SUPPLY PRESSURE" ALARM ERRORS OCCURRED WHILE THE DEVICE WAS ON A PATIENT. A REVIEW OF THE DIAGNOSTIC REPORT (DRPT) REVEALED THAT THE 1208 "OXYGEN NOT AVAILABLE" AND 1209 "LOW O2 SUPPLY PRESSURE" ALARM ERRORS WERE LOGGED. ACCORDING TO THE HOSPITAL, THE DEVICE RAN SEVERAL TIMES, BUT THE ERRORS DID NOT REAPPEAR. A FIELD SERVICE TECHNICIAN INSPECTED THE DEVICE, BUT THE ERRORS COULD NOT BE CONFIRMED. NO DEVICE MALFUNCTION, PERFORMANCE FAILURE, OR COMPONENT ISSUE WAS REPORTED OR IDENTIFIED. A REPAIR QUOTE WAS SENT TO THE CUSTOMER FOR APPROVAL. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522980 ↗
• MalfunctionJun 16, 2026Unstable

  PHILIPS RECEIVED A COMPLAINT BY A FIELD SERVICE TECHNICIAN ON THE V60 INDICATING THAT THE ATTACHMENT PART FOR RUBBER FEET OF THE CENTRAL PROCESSING UNIT (CPU) TRAY COVER WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. A FIELD SERVICE TECHNICIAN EVALUATED THE DEVICE AND OBSERVED THAT THE ATTACHMENT PART FOR RUBBER FEET OF THE CPU TRAY COVER WAS DEFORMED. THE FIELD SERVICE TECHNICIAN ULTIMATELY REPLACED THE CPU TRAY COVER, CONFIRMED THAT THE SOFTWARE VERSION OF THE DEVICE WAS 3.20, CONDUCTED A COMPREHENSIVE INSPECTION OF THE DEVICE, CLEANED THE DEVICE, PERFORMED FUNCTIONAL TESTS, VERIFIED THAT THE ISSUE WAS RESOLVED, AND RETURNED THE DEVICE 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. BASED ON THE INFORMATION PROVIDED, THE ALLEGED MALFUNCTION IMPACTED THE USER¿S ABILITY TO USE THE DEVICE PROPERLY. A REVIEW OF THE RISK MANAGEMENT FILE WAS PERFORMED, AND IT WAS DETERMINED THAT THIS COMPLAINT IS A REPORTABLE MALFUNCTION AS THERE WAS A MOUNTING ISSUE, CAUSING THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519807 ↗
• MalfunctionJun 5, 2026Pressure Problem

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A HIGH O2 SUPPLY PRESSURE ALARM. NO PATIENT OR USER HARM REPORTED. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. WHEN THE ALARM WAS OBSERVED, THE CUSTOMER CONNECTED ANOTHER V60 TO THE SAME OXYGEN SETUP AND THERE WAS NO OBSERVED ISSUE. THE DEVICE WAS COLLECTED FOR EVALUATION AT A REPAIR CENTER. ON 24MAY2026, AN AUTHORIZED SERVICE PROVIDER COMPLETED A RUNNING TEST WITH A HIGH PRESSURE OXYGEN POUNDS PER SQUARE INCH GAUGE (PSIG) OF 45 AND 87 CONNECTED, BUT THE ALLEGED ISSUE COULD NOT BE REPRODUCED. THE ASP CHECKED THE EVENT LOG OF THE DEVICE AND CONFIRMED A PREVIOUS OCCURRENCE OF THE HIGH O2 SUPPLY PRESSURE ALARM, AS WELL AS AN OXYGEN NOT AVAILABLE ALARM CODE. AN INSPECTION WAS COMPLETED ON THE DEVICE, BUT NO ABNORMALITIES WERE FOUND. THE CUSTOMER REQUESTED THAT THE DEVICE BE RETURNED WITHOUT ANY FURTHER REPAIR OR 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 25411714 ↗
• MalfunctionJun 2, 2026Inadequate User Interface

  A CUSTOMER REPORTED A V60 VENTILATOR EXPERIENCED A CONDITION WHERE THE SCREEN LOCK FEATURE COULD NOT BE UNLOCKED BY PRESSING THE "ENTER" BUTTON. THERE WAS NO PATIENT INVOLVEMENT, HARM, OR INJURY REPORTED AT THE TIME THE ISSUE WAS DISCOVERED. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE VENTILATOR ONSITE AND CONFIRMED THE REPORTED FAILURE BEFORE RETRIEVING THE DEVICE FOR DEPOT-LEVEL SERVICE. DURING EVALUATION AT THE REPAIR CENTER, THE REPORTED FAILURE MODE COULD NOT BE DUPLICATED, AND THE DEVICE MET ALL REQUIRED ENGINEERING SPECIFICATIONS. AS A PREVENTIVE MEASURE TO MITIGATE RECURRENCE, THE SWITCH PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED. FOLLOWING THE COMPONENT REPLACEMENT, THE VENTILATOR SUCCESSFULLY PASSED ALL REQUIRED PERFORMANCE VERIFICATION TESTS PER MANUFACTURING STANDARDS AND WAS RETURNED TO SERVICE. IF /WHEN COMPONENTS ARE RECEIVED, AN EVALUATION WILL BE CONDUCTED AND AN ADDITIONAL REPORT WILL BE SUBMITTED. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364251 ↗
• MalfunctionJun 1, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS MISALIGNMENT IN THE TOUCH POSITION. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THERE WAS MISALIGNMENT IN THE TOUCH POSITION. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE. THE PHILIPS ASP ATTEMPTED A CALIBRATION OF THE TOUCHSCREEN, BUT THIS DID NOT RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP THEN REPLACED THE TOUCHSCREEN TO RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP REPLACED THE TOUCHSCREEN 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 MISALIGNMENT IN THE TOUCH POSITION COULD BE REPRODUCED DURING ONSITE EVALUATION OF THE DEVICE. THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY TOUCHSCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350706 ↗
• MalfunctionMay 26, 2026Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE RESTARTED UNEXPECTEDLY. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE PATIENT INFORMATION FROM THE TIME OF THE EVENT WAS NOT DISCLOSED. THE CUSTOMER STATED THAT THE DEVICE WAS BEING USED WHEN A PHYSICIAN APPROACHED THE DEVICE TO ADJUST ITS SETTINGS AND THE SCREEN WENT BLACK. IT WAS NOT KNOWN IF AN ALARM OCCURRED DURING THIS INITIAL OBSERVATION. THE DEVICE PRODUCED A "RESTARTING" MESSAGE, AFTER WHICH THE DEVICE RETURNED TO OPERATING AS EXPECTED. THE DEVICE WAS THEN INSPECTED AGAIN AND THE "RESTARTING" MESSAGE STILL SHOWED, WITH A LOW PRIORITY ALARM ALLEGING TO BE OCCURRING DURING THE SECOND INSPECTION. THE "RESTARTING" MESSAGE WAS CLEARED ONCE THE DEVICE WAS POWERED DOWN AND THEN BACK ON. THE DEVICE WAS THEN WITHDRAWN FROM USE TO BE EVALUATED. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280198 ↗
• MalfunctionMay 20, 2026Unexpected Shutdown

  IT WAS REPORTED BY FACILITY MEDICAL ENGINEER A PHILIPS RESPIRONICS V60 VENTILATOR TURNED ITSELF OFF AND RESTARTED UNEXPECTEDLY WHILE IT WAS ACTIVELY BEING USED ON A PATIENT. A "RESTART" MESSAGE APPEARED ON THE SCREEN, AND THE DEVICE THEN WENT BACK TO NORMAL OPERATION. THE PATIENT WAS QUICKLY MOVED TO A DIFFERENT VENTILATOR. THERE WAS NO DELAY IN THERAPY, NO MEDICAL INTERVENTION WAS NEEDED, AND NO HARM OR INJURIES OCCURRED. THE HOSPITAL STAFF WAS BLOCKED FROM USING THE MACHINE, SO THEY IMMEDIATELY REMOVED IT FROM SERVICE AND SENT IT TO BE FIXED. A SERVICE ENGINEER TESTED THE DEVICE BUT COULD NOT MAKE THE RESTART HAPPEN AGAIN ON THE TEST BENCH. HOWEVER, WHEN THEY CHECKED THE MACHINE¿S INTERNAL COMPUTER HISTORY LOGS, THEY CONFIRMED THE MALFUNCTION HAPPENED. THE COMPUTER LOGGED TWO CODES AT THE EXACT SAME TIME: CODE 1101 (WHICH MEANS THE VENTILATOR RESTARTED BECAUSE IT HIT A PROCESSING ERROR) AND CODE 3007. CODE 1101 HAPPENS WHEN THE VENTILATOR'S MAIN COMPUTER BRAIN GETS CONFUSED BY UNREADABLE DATA, A PROGRAM GLITCH, OR A SOFTWARE ERROR. WHEN THIS HAPPENS, THE MACHINE IS DESIGNED TO QUICKLY RESTART ITSELF TO CLEAR ITS MEMORY AND FIX THE PROBLEM. NORMALLY, A CODE 1101 REQUIRES A TECHNIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233415 ↗
• MalfunctionMay 18, 2026Failure to Sense

  THE SERVICE ENGINEER (SE) REPORTED THAT THE V60 VENTILATOR DISPLAYED A "CHECK VENT: PROXIMAL PRESSURE SENSOR AUTO-ZERO FAILED" DIAGNOSTIC CODE (110A). NO PATIENT INVOLVEMENT WHEN THE ISSUE WAS OBSERVED. NO USER IMPACT REPORTED; THE DEVICE WAS NOT IN SERVICE WHEN THE ISSUE OCCURRED. WHILE SERVICING THE DEVICE, THE EVENT LOG WAS REVIEWED BY THE SE, AND IT WAS CONFIRMED THAT A "CHECK VENT: PROXIMAL PRESSURE SENSOR AUTO-ZERO FAILED" DIAGNOSTIC CODE (110A) WAS RECORDED. THE ISSUE WAS CONFIRMED VIA THE EVENT LOG. THE SE DID NOT SPECIFY IF THE ERROR CODE WAS REPLICATED DURING SERVICE. THE SE REPLACED THE SOLENOID VALVES (3 AND 4), AND DATA ACQUISITION (DA) BOARD TO RESOLVE THE ISSUE. NO OTHER ABNORMALITIES WERE FOUND. THE DEVICE WAS CHECKED, CLEANED, AND TESTED; THE DEVICE WAS THEN RETURNED TO THE CUSTOMER. BASED ON THE INFORMATION PROVIDED, THE DEVICE HAD MALFUNCTIONED, AND THE DEVICE DISPLAYED A "CHECK VENT: PROXIMAL PRESSURE SENSOR AUTO-ZERO FAILED" DIAGNOSTIC CODE (110A). THE CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A FAILURE WITH THE SOLENOID VALVES (3 AND 4), AND DA BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200883 ↗
• MalfunctionMay 15, 2026Failure to Power Up

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185229 ↗
• MalfunctionMay 7, 2026Device Alarm System

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DISPLAYED A "BACKUP ALARM FAILED" ERROR CODE (1104). THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE WAS OBSERVED. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REPORTED THAT DURING SET UP, THE V60 VENTILATOR DISPLAYED A "BACKUP ALARM FAILED" ERROR CODE (1104). IT WAS REPORTED THAT THE ERROR CODE WAS CONFIRMED, AND THE DEVICE WAS REPLACED. THE DEVICE WAS EVALUATED BY A SERVICE ENGINEER (SE), AND IT WAS REPORTED THAT THE ISSUE WAS NOT DUPLICATED AT THE REPAIR CENTER. THE SE REVIEWED THE EVENT LOG, AND IT WAS CONFIRMED THAT THE DEVICE HAD RECORDED A "CHECK VENT: BACKUP ALARM FAILED" ERROR MESSAGE (1104). THE SE NOTED THAT THE CENTRAL PROCESSING UNIT (CPU) NEEDED TO BE REPLACED. THE CUSTOMER WAS PROVIDED WITH A QUOTE FOR SERVICE. INVESTIGATION ONGOING / RESOLUTION PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114077 ↗
• MalfunctionMay 7, 2026Device Alarm System

  PHILIPS RECEIVED A COMPLAINT BY A FIELD SERVICE TECHNICIAN ON THE V60 INDICATING THAT A 1102 "PRIMARY ALARM 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. A FIELD SERVICE TECHNICIAN EVALUATED THE DEVICE AND DISCOVERED THAT A 1102 "PRIMARY ALARM FAILED" ALARM ERROR OCCURRED. THE FIELD SERVICE TECHNICIAN ULTIMATELY REPLACED SPEAKER #1, CHECKED THAT SOFTWARE VERSION 3.20 WAS INSTALLED, CONDUCTED A COMPREHENSIVE INSPECTION, CLEANED THE DEVICE, PERFORMED RUNNING AND FUNCTIONAL TESTS, AND VERIFIED THAT THE ISSUE WAS RESOLVED AS NO OTHER MALFUNCTION WAS FOUND. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD 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 25112866 ↗
• MalfunctionMay 5, 2026Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE HAD SHUTDOWN UNEXPECTEDLY. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE DEVICE WAS BEING SERVICED AT A REPAIR CENTER ON 22APR2026 WHEN AN AUTHORIZED SERVICE PROVIDER (ASP) OBSERVED THE DEVICE POWER DOWN UNEXPECTEDLY. ON 27APR2026, THE ASP REPLACED THE POWER MANAGEMENT (PM) CIRCUIT BOARD ASSEMBLY (PCBA) TO RESOLVE THE ISSUE. FOLLOWING THE PART REPLACEMENT THE ASP COMPLETED A CLEANING, RUNNING TEST, AND FUNCTIONAL TEST. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086764 ↗
• MalfunctionMay 1, 2026Failure to Deliver

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT AN "OXYGEN NOT AVAILABLE" ALARM OCCURRED. IT WAS NOTED THAT THE DEVICE KEPT OPERATING WHEN THE ISSUE WAS OBSERVED. 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. THE DEVICE WAS SWAPPED OUT WITH A DIFFERENT DEVICE. THERE WAS NEITHER DELAY IN THERAPY NOR MEDICAL INTERVENTION REPORTED DUE TO THE ISSUE OTHER THAN THE VENTILATOR SWAP. THERE WAS NO REPORT OF PATIENT OR USER HARM. IT WAS DOCUMENTED THAT THE DEVICE WAS RUN IN THE MEDICAL ENGINEER CENTER, BUT THE REPORTED ISSUE WAS NOT REPRODUCED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059359 ↗
• MalfunctionMay 1, 2026Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE HAD UNEXPECTEDLY TURNED OFF DURING A TEST RUN. 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 STATED THAT, DURING A TEST RUN, AN UNKNOWN ALARM SOUNDED AND THEN THE DEVICE TURNED OFF, THEN THE DEVICE RECOVERED ON ITS OWN. THE DEVICE WAS REPLACED WITH ANOTHER UNIT SO THAT IT COULD BE TAKEN TO A SERVICE CENTER TO BE EVALUATED BY AN AUTHORIZED SERVICE PROVIDER (ASP). AN ASP EVALUATED THE DEVICE BUT WAS UNABLE TO REPRODUCE THE ISSUE. THE ASP CHECKED THE DEVICE'S EVENT LOG AND FOUND THAT THE CODE FOR A CHECK VENT: VENTILATOR RESTARTED ALARM, 1101, WAS LOGGED. THIS OCCURRED IN CONJUNCTION WITH A DIAGNOSTIC CODE 3007. PER THE V60 SERVICE MANUAL, ERROR 1101 INDICATES THAT THE VENTILATOR RESTARTED DUE TO ANOMALIES DETECTED DURING OPERATION. THIS COULD INCLUDE INVALID OR CORRUPTED INFORMATION, UNANTICIPATED SITUATIONS, OR OBJECT ALLOCATION ERRORS. THE CUSTOMER WAS INFORMED THAT IF DIAGNOSTIC CODE 1101 OCCURS IN CONJUNCTION WITH DIAGNOSTIC CODE 3007 (SOFTWARE EXCEPTION), NO ACTION IS REQUIRED. WITH NO ACTION BEING REQUIRED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058387 ↗