BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20514121 · Received October 23, 2024

    Report

    Report Number
    2518422-2024-64941
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 18, 2024
    Report Date
    January 31, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, THE BENCH SERVICE ENGINEER (BSE) REPLACED THE AC POWER CORD TO RESOLVE THE ELECTRICAL SAFETY TEST FAILURE. FOLLOWING THE PART REPLACEMENT THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED, CONFIRMING A RETURN TO FULL FUNCTIONALITY. THE BSE RESTORED THE DEVICE TO FACTORY SETTINGS PRIOR TO SENDING THE DEVICE 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.

    Additional Manufacturer Narrative · 0

    E1: REPORTING ADDRESS POSTAL: (B)(6). REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE ALTERNATING CURRENT (AC) POWER CABLE RESISTANCE WAS OUT OF SPECIFICATION. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A PHILIPS BENCH SERVICE CENTER. WHILE PERFORMING AN ELECTRICAL SAFETY TEST, THE BSE OBSERVED THE THAT THE AC CABLE EXCEEDED THE ALLOWABLE RESISTANCE RANGE ESTABLISHED BY THE MANUFACTURER. 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
    317020 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown