BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XVIVO ORGAN CHAMBER

    MDR report key: 14140108 · Received April 19, 2022

    Report

    Report Number
    3007710603-2022-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Report Date
    April 7, 2022
    Manufacturer
    XVIVO PERFUSION AB
    Product Code
    PHO
    UDI-DI
    07350069520074
    PMA / PMN Number
    P180014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MALFUNCTION ACCORDING TO THE REPORTER THREE DEVICES WITH UNSEALED STERILE BARRIER WERE FOUND AT USER FACILITY QUALITY INSPECTION WHEN RECEIVING THE GOODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089619 XVIVO ORGAN CHAMBER ORGAN CHAMBER PHO XVIVO PERFUSION AB 19020 13801 07350069520074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown