BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11788281 · Received May 6, 2021

    Report

    Report Number
    2031642-2021-03632
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 8, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRONT BEZEL WAS RETURNED FOR FAILURE INVESTIGATION. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED NAVIGATION RING FAILURES WERE DUE TO LIQUID INGRESS.

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. G5: 510K: K102985. B4: (B)(6) 2021. THE AUTHORIZED SERVICE PERSONNEL REPLACED THE FRONT BEZEL TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE NAV RING IS NOT OPERATIONAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684664 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown