BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY

    MDR report key: 5089822 · Received September 19, 2015

    Report

    Report Number
    3010293992-2015-00163
    Event Type
    Malfunction
    Date Received
    September 19, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 25, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM USA REPORTED: I WENT TO UNPLUG IT AND THE COVER CAME OFF IN MY HAND. RECKON I'LL HAVE TO GLUE IT BACK TOGETHER. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. PATIENT INVOLVEMENT: NO. HUMAN HARM: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620979 POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1