BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY

    MDR report key: 5027044 · Received August 25, 2015

    Report

    Report Number
    3010293992-2015-00158
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 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
    WA, 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: "(B)(6) CALLED IN TO COMPLAIN ABOUT A RECURRING PROBLEM WITH THE SAPPHIRE DEVICE POWER CORDS. HE STATED THAT HE HAS 6 OF THEM WHICH HAD THE TOP AND BOTTOM END OF THE CORDS ARE BROKEN AT THE GLUE LINE. LAST MONTH, A NURSE WAS REPORTEDLY ELECTROCUTED WHILE PLUGGING THE DAMAGED POWER CORD TO A POWER OUTLET. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. HUMAN HARM: YES. DETAILS: A MONTH AGO, A NURSE WAS ELECTROCUTED PLUGGING A DAMAGED POWER SUPPLY CORD TO A POWER OUTLET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561961 POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD. 5014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other