BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4972997 · Received August 3, 2015

    Report

    Report Number
    3010293992-2015-00130
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 15, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    MRZ
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "I WAS CONTACTED VIA TEXT AND VOICEMAIL THAT THE ACCOUNT NOW HAS 3 BROKEN AC POWER SUPPLIES IN THE LAST 24 HOURS. THE THIRD OCCURRENCE WAS AFTER AN INSPECTION OF THE CORDS. IT WAS NOTED THAT THIS CORD WAS BROKEN APART. THE ACCOUNT WILL NOT SUPPLY ME ANY FURTHER DETAIL UNTIL THEY COMPLETE THEIR INTERNAL INCIDENT REPORTS AND QUALITY ASSURANCE MEASURES. THEY ARE REPORTING TO MEDWATCH. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. SERIOUS INJURY OR DEATH: NO. HUMAN HARM: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504199 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK