BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3081345 · Received April 26, 2013

    Report

    Report Number
    2124215-2013-04452
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 4, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROGRAMMER WAS PERFORMED. LIQUID CRYSTAL DISPLAY (LCD) WAS NOT BACKLIT AND THE INVERTER WAS OVERHEATED AND MELTED. THE PROGRAMMER PASSED ALL INCOMING FUNCTIONAL TESTS WITH A FUNCTIONAL INVERTER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER'S SCREEN WAS GOING DARK EVEN IF IT WAS BEING REBOOTED. THE FIELD REPRESENTATIVE COULD STILL PUSH THE BUTTONS BUT CANNOT SEE WHAT WAS BEING DONE ON THE SCREEN. THIS PROGRAMMER IS OUT OF SERVICE AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180769 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1