BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4973000 · Received August 3, 2015

    Report

    Report Number
    3010293992-2015-00131
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q CORE MEDICAL LTD (MFR) IS REPORTING ON BEHALF OF HOSPIRA.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM CANADA: "CUSTOMER CHUM PAV NOTRE DAME RECEIVED POWER CORD THAT IS DETACHED. THE PART WAS UNGLUED. WAS THERE A PRIME PERFORMED: NO. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. HUMAN HARM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504980 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY 5114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK