BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4886491 · Received July 1, 2015

    Report

    Report Number
    3010293992-2015-00108
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 23, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q CORE MED LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "2 ADAPTER IS BROKEN. NEW TYPE OF ADAPTER IS FRAGILE. PRIOR TO PATIENT USE. GLUE NOT WORKING WELL. ADAPTER IS OPEN WITH WIRES EXPOSED. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO HUMAN HARM: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428187 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY

    Patients

    Seq Age Sex Outcome Treatment
    1