BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3910499 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09368
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 9, 2014
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROGRAMMER WAS PERFORMED. THE PROGRAMMER WAS POWERED ON TO CHECK FOR BOOT-UP ISSUES. ANALYSIS FOUND THAT THERE WAS AN ISSUE WITH A PART OF THE INTERNAL CIRCUITRY RELATED TO THE PROGRAMMER SCREEN AND THERE WAS EVIDENCE OF OVERHEATING. THE COMPONENT WAS THEN REPLACED, AND THE PROGRAMMER PASSED ALL OTHER TESTING. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER WAS NOT WORKING. THE SCREEN WAS ALL DARK AND IT WILL FLASH WHEN POWERED UP. THE FIELD REPRESENTATIVE HAS TRIED REBOOTING SEVERAL TIMES BUT WAS STILL NOT RESOLVED. THE PROGRAMMER WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388711 ZOOM LWS EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1