BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3761272 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-06765
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 12, 2014
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED ANALYSIS CONFIRMED THAT THE ERROR HAD BEEN CAUSED BY THE OVERHEATED LOWER SPOOL IN THE INVERTER PCB. ALSO, THE INVERTER COVER WAS DAMAGED. THE INVERTER, AND THE DAMAGED COVER WAS THEN CHANGED AND ERROR WAS RESOLVED. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS NOTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PROGRAMMER SCREEN WENT BLANK FOLLOWING START UP. THE PROGRAMMED WAS RESTARTED MULTIPLE TIMES BUT THE SAME ERROR WAS OBSERVED. THE PROGRAMMER WAS RETURNED TO BOSTON SCIENTIFIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240648 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1