BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 5409481 · Received February 4, 2016

    Report

    Report Number
    2124215-2016-01950
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    September 17, 2015
    Report Date
    October 12, 2015
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PROGRAMMER WAS THOROUGHLY INSPECTED AND ANALYSED. THE PROGRAMMER WAS CONFIRMED TO EXHIBIT A PRODUCT PERFORMANCE ISSUE. THE PROGRAMMER WAS OPENED IN ORDER TO ASSESS THE INTERNAL COMPONENTS. DETAILED INSPECTION IDENTIFIED AN INTERNAL ELECTRICAL COMPONENT THAT HAD SHORTED RESULTING IN THE REPORTED CLINICAL OBSERVATIONS. FOLLOWING REPAIR OF THE UNIT, THIS PROGRAMMER OPERATED AS EXPECTED. THE DEVICE MANUFACTURE DATE FOR THIS PRODUCT IS JULY 25, 2006.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER DISPLAYED BLACK SCREEN AND DID NOT BOOT UP. PROGRAMMER WAS RETURNED BACK TO THE LABORATORY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69387 ZOOM LWS EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1