BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE POWER SUPPLY

    MDR report key: 4972938 · Received August 3, 2015

    Report

    Report Number
    3010293992-2015-00135
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 22, 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
    OR, 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: "CASING PULLED APART ON BATTERY. BIOMED CONTACT (B)(6) WAS ABLE TO RESEAL THE CASING TOGETHER WITH GLUE AND RETURN TO SERVICE. A 4TH OCCURRENCE OF THIS HAPPENING OVER THE LAST 6 MONTHS (NOT ALL REPORTED). CUSTOMER BELIEVES THAT THE SEALANT USED ON THE CASING IS NOT STRONG ENOUGH, OR THAT THE AMOUNT USED IS TOO SMALL. THE CUSTOMER WOULD BE WILLING TO DISCUSS THIS FURTHER WITH Q-CORE SINCE THEY BELIEVE THIS IS A REPEATABLE, AND POTENTIALLY AVOIDABLE ISSUE. DELAY IN THERAPY: UNK. NEED FOR MEDICAL INTERVENTION: UNK. DEATH OR SERIOUS INJURY: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504886 Q CORE POWER SUPPLY POWER SUPPLY MRZ Q CORE MEDICAL LTD POWER SUPPLY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other