BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23637492 · Received November 24, 2025

    Report

    Report Number
    2518422-2025-055923
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 11, 2025
    Report Date
    June 1, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT AN OVP CIRCUIT FAILURE OCCURRED. AT THE SERVICE CENTER, THE ERROR CODES FOR THE OVP CIRCUIT FAILURE WERE CONFIRMED. THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED AT THE REPAIR CENTER TO RESOLVE THE REPORTED ISSUE. THE SERVICE CENTER REPLACED THE MC PCBA 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414567 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown