BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4972939 · Received August 3, 2015

    Report

    Report Number
    3010293992-2015-00134
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 20, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "POWER CORD CAME APART WHERE IT PLUGS INTO A/C OUTLET. THIS WAS FOUND DURING ANNUAL CERTIFICATION TESTING. THIS IS THE 5TH NEW STYLE POWER CORD TO DO THIS IN THE LAST 2 WEEKS. NURSES HAVE BEEN SHOCKED WHEN THIS HAPPENS. DELAY IN THERAPY: UNK. NEED FOR MEDICAL INTERVENTION: UNK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504416 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other