BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11721873 · Received April 25, 2021

    Report

    Report Number
    2031642-2021-03500
    Event Type
    Malfunction
    Date Received
    April 25, 2021
    Date of Event
    March 26, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:25MAY2021. G5:510K: K102985. B4:21JUN2021. THE CUSTOMER CONFIRMED THE REPORTED FAILURE. THE CUSTOMER REPLACED THE USER INTERFACE (UI) TO RESOLVE THE ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT OPERATES BUT THERE IS NO BACK LIGHT. PREVIOUSLY, THE POWER MANAGEMENT BOARD (PM) WAS REPLACED AND NOW THE UNIT OPERATES BUT NO DISPLAY. THE UNIT WAS NOT IN USE, AND THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618050 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1