BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20688244 · Received November 14, 2024

    Report

    Report Number
    2518422-2024-70408
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 10, 2024
    Report Date
    April 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS FIRST OBSERVED BY THE BENCH SERVICE ENGINEER (BSE) AT THE BENCH REPAIR CENTER. THE RESISTANCE OF THE ALTERNATING CURRENT (AC) POWER CABLE WAS FOUND TO EXCEED THE PERMITTED LIMITS OF THE ELECTRICAL SAFETY TEST. THE BSE DETERMINED THAT THE AC POWER CABLE NEEDED TO BE REPLACED. THE BSE REPLACED THE AC POWER CABLE AT THE BENCH REPAIR CENTER TO RESOLVE THE ELECTRICAL SAFETY ISSUE. FOLLOWING THE PART REPLACEMENT, THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED. IT WILL BE RETURNED TO THE CUSTOMER FULLY FUNCTIONAL AND 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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE FAILED THE ELECTRICAL SAFETY TEST. 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 FIRST OBSERVED BY THE BENCH SERVICE ENGINEER (BSE) AT THE BENCH REPAIR CENTER. THE RESISTANCE OF THE ALTERNATING CURRENT (AC) POWER CABLE WAS FOUND TO EXCEED THE PERMITTED LIMITS OF THE ELECTRICAL SAFETY TEST. THE BSE DETERMINED THAT THE AC POWER CABLE NEEDED TO BE REPLACED. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205091 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown