BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY

    MDR report key: 5099823 · Received September 24, 2015

    Report

    Report Number
    3010293992-2015-00168
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 2, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM USA: "CUSTOMER HAS A BROKEN SAPPHIRE AC ADAPTER WITH ELECTRICAL COMPONENTS SHOWING. PICTURE ATTACHED. NO ONE WAS SHOCKED. PATIENT INCIDENT: THIS DID NOT CAUSE A PATIENT INCIDENT OR A NEGATIVE EFFECT ON PATIENT CARE. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. SERIOUS INJURY/DEATH: NO. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633576 POWER SUPPLY POWER SUPPLY (FIXED HEADS )ASM MRZ Q CORE MEDICAL LTD. 0915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other