BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12005451 · Received June 15, 2021

    Report

    Report Number
    2031642-2021-04101
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 22, 2021
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:10AUG2021. THE POWER SWITCH OVERLAY COULD NOT BE REPLACED DUE TO END OF SUPPORT, AND NO PARTS WERE AVAILABLE. THE CUSTOMER HAS DECIDED TO RETIRE THE UNIT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED KEYPAD IS NOT FUNCTIONING. THE CUSTOMER SUSPECTED THE POWER SWITCH OVERLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899801 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V200

    Patients

    Seq Age Sex Outcome Treatment
    1