BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 5211270 · Received November 9, 2015

    Report

    Report Number
    2124215-2015-14568
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 20, 2015
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PROGRAMMER WAS THOROUGHLY INSPECTED AND ANALYZED. 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. THE DEVICE MANUFACTURE DATE FOR THIS PRODUCT IS DECEMBER 21, 2005.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER DISPLAYED BLACK SCREEN UPON BOOT UP. FIELD REPRESENTATIVE RETURNED THE UNIT BACK TO THE LABORATORY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741143 ZOOM LWS EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1