BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11682676 · Received April 16, 2021

    Report

    Report Number
    2031642-2021-03408
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 17, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. G5: 510K: K102985. B4: (B)(6) 2021. THE CUSTOMER CONFIRMED THE REPORTED FAILURE. THE CUSTOMER REPLACED THE FRONT BEZEL WITH THE NAVIGATION RING REPLACEMENT AND ALONG WITH THE SCREWS AND GASKET. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NAV RING IS NOT WORKING WHEN ADJUSTING THE SETTINGS. 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
    576970 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1