BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS® PLUS INSTRUMENT

    MDR report key: 5151051 · Received October 15, 2015

    Report

    Report Number
    3005290010-2015-00010
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    September 13, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    UDI-DI
    04049934004636
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SCREEN OF THE CLINIMACS PLUS INSTRUMENT REMAINED BLANK AFTER BEING SWITCHED ON. THE FAN OF THE INSTRUMENT TURNED CORRECTLY. THE CUSTOMER CHECKED THE INCOMING POWER SUPPLY AND THE CONNECTIONS AND THEY WERE OK. A REPAIR OF THE CLINIMACS PLUS INSTRUMENT IS ORGANIZED BY MILTENYI BIOTEC GMBH. BASED ON THE INFORMATION PROVIDED, HARM TO THE PATIENT CAN BE EXCLUDED. (B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682565 CLINIMACS® PLUS INSTRUMENT CLINIMACS® PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH N/A 04049934004636

    Patients

    Seq Age Sex Outcome Treatment
    1