BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 22442161 · Received July 8, 2025

    Report

    Report Number
    2518422-2025-047927
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 28, 2025
    Report Date
    August 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESPIRONICS V60/V60 PLUS VENTILATOR USER MANUAL, CHAPTER 1: WARNINGS, CAUTIONS, AND NOTES STATES, ¿TO ENSURE ACCURACY OF OXYGEN ADMINISTRATION AND TO MONITOR FOR THE PRESENCE OF CONTAMINATION (INCORRECT GAS CONNECTED), USE AN EXTERNAL OXYGEN MONITOR TO VERIFY THE OXYGEN CONCENTRATION IN THE DELIVERED GAS.¿ CHAPTER 5: SETTING UP THE VENTILATOR FOR USE STATES, ¿TO REDUCE THE RISK OF HYPOXIA, CONNECT ONLY OXYGEN TO THE HIGH-PRESSURE CONNECTOR AT THE REAR OF THE VENTILATOR. THE RESPIRONICS V60/V60 PLUS VENTILATOR IS DESIGNED TO USE AMBIENT AIR AND HIGH PRESSURE 100% OXYGEN. NO OTHER GASES SHOULD BE USED.¿ CHAPTER 9: ALARMS, MESSAGES, AND TROUBLESHOOTING STATES, WHEN THE MESSAGE ¿OXYGEN NOT AVAILABLE¿ APPEARS ON THE SCREEN THEN IT COULD MEAN, ¿OXYGEN SUPPLY PRESSURE OUT OF RANGE, OXYGEN DEVICE FAILED, AIR FLOW SENSOR AND/OR OXYGEN FLOW SENSOR CALIBRATION FAILED, OR OXYGEN INLET PRESSURE SENSOR CALIBRATION FAILED. THE VENTILATOR DISCONTINUES OXYGEN SUPPORT. CHECK THE PATIENT. CHECK IF HIGH/LOW O2 SOURCE IS THE PROBLEM AND CORRECT. IF PROBLEM PERSISTS, PROVIDE ALTERNATIVE VENTILATION. HAVE THE VENTILATOR SERVICED.¿. A FOLLOW UP WAS PERFORMED WITH THE KEY MARKET (KM), AND THE RESPONDER CLARIFIED THAT THE SECOND INTERFACE WAS A CENTRAL OXYGEN SUPPLY INTERFACE. IT WAS ALSO REPORTED THAT THE OXYGEN MASK WAS CHANGED DURING THE PROCESS, AND WHEN THE PATIENT WAS PROVIDED WITH OXYGEN THROUGH THE VENTURI MASK, A SEPARATE OXYGEN MASK WAS USED. THE KM RESPONDER REPORTED THAT THE HOSPITAL REPAIRED THE DEVICE AND RETURNED THE DEVICE TO SERVICE; HOWEVER, THE KM REPORTED THAT THE HOSPITAL DID NOT SPECIFY HOW THE ISSUE WAS RESOLVED, AND THE KM WAS UNABLE TO PROVIDE ANY FURTHER DETAILS REGARDING THE RESOLUTION. THE DEVICE WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    A CLINICAL REASSESSMENT WAS PERFORMED BASED ON THE ADDITIONAL DETAILS PROVIDED BY THE KEY MARKET IN THE GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED. BASED ON THE CURRENT INFORMATION THAT THE DEVICE WAS REPAIRED AND THE USER MANUAL STATING AN ISSUE SUCH AS THIS COULD BE RELATED TO THE AIR FLOW SENSOR AND/OR OXYGEN FLOW SENSOR CALIBRATION OR OXYGEN INLET PRESSURE SENSOR CALIBRATION THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY. IT IS UNCLEAR IF IT WAS A PRODUCT DEFECT, MALFUNCTION, AND/OR USE ERROR BUT IT LIKELY CAUSED THE SERIOUS INJURY AND/OR ADVERSE EVENT. THE REPAIR INVESTIGATION AND THE EVENT LOG ARE UNLIKELY TO BE RETURNED AS PER PATIENT RESPONSE. NO FURTHER ACTIONS ARE CURRENTLY REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT ONE HOUR AFTER THE PATIENT WAS CONNECTED TO THE V60 VENTILATOR, THE DEVICE DISPLAYED A "NO OXYGEN SUPPLY" ALARM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LABORED BREATHING, AND THEIR BLOOD OXYGEN LEVEL DROPPED TO 40%. THE PATIENT WAS SWITCHED TO ANOTHER INTERFACE, BUT THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS IMMEDIATELY PROVIDED WITH OXYGEN THROUGH A VENTURI MASK, AND THEIR BLOOD OXYGEN WAS RAISED LEVEL TO 92%, ALLEVIATING THE BREATHING DIFFICULTY. NO OTHER PATIENT DISCOMFORT WAS REPORTED. WHILE CHECKING THE DEVICE, THE CUSTOMER REPORTED THAT THE OXYGEN CONNECTION WAS INTACT, AND THE OTHER SUPPLY PORTS WERE FUNCTIONING NORMALLY. THE DEVICE WAS SENT TO THE BENCH FOR EVALUATION. THE COMPLAINT WAS CLINICALLY ASSESSED BY A PHILIPS CLINICAL EXPERT AND DETERMINED THAT BASED ON THE INFORMATION AND EVIDENCE CURRENTLY AVAILABLE, DEVICE CAUSE AND/OR CONTRIBUTION TO THE REPORTED EVENT OF BLOOD OXYGEN LEVEL DROPPING TO 40% CANNOT CURRENTLY BE CONFIRMED NOR REFUTED. FURTHER GOOD FAITH EFFORTS AND INFORMATION GATHERING ARE REQUIRED TO DETERMINE DEVICE CAUSE AND/OR CONTRIBUTION TO THE PATIENT HARMS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672568 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L