BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4987897 · Received August 10, 2015

    Report

    Report Number
    3010293992-2015-00151
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 6, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: "5 BROKEN POWER CORDS. OUTER HOUSING IS COMING APART. SAMPLES DISCARDED. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. SERIOUS INJURY OR DEATH: NO. HUMAN HARM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521787 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1