BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4886509 · Received July 1, 2015

    Report

    Report Number
    3010293992-2015-00111
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "ISSUE IS THE HOUSING FOR THE POWER ADAPTER HAS COMPLETELY FALLEN APART. PATIENT INVOLVEMENT: NO. HUMAN HARM: NO. DELAY IN THERAPY: UNKNOWN. NEED FOR MEDICAL INTERVENTION: UNKNOWN" ADDITIONAL INFORMATION RECEIVED ON JUN 17, 2015: RECENTLY, THE POWER ADAPTERS HAVE BEEN BREAKING AT THE HOUSING PART. IT FALLS APART COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428277 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY 2014

    Patients

    Seq Age Sex Outcome Treatment
    1