BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY (FIXED HEADS )

    MDR report key: 5339841 · Received January 4, 2016

    Report

    Report Number
    3010293992-2016-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Report Date
    December 9, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A COSTUMER FROM USA: "POWER CORD 15072-000-0005 LOT 4814 OUTLET BOX BROKEN. DELAY IN THERAPY: UNKNOWN; NEED FOR MEDICAL INTERVENTION: UNKNOWN; SERIOUS INJURY/DEATH: NO. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270 POWER SUPPLY (FIXED HEADS ) POWER SUPPLY (FIXED HEADS ) MRZ Q CORE MEDICAL LTD. 4814

    Patients

    Seq Age Sex Outcome Treatment
    1