BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3210258 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07993
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 16, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT FROM ANALYSIS, IT WAS CONFIRMED THAT ONE OF THE COMPONENTS WITHIN THE PRODUCT CIRCUITRY BECAME DEFECTIVE AND BURNT; WHICH CAUSED THE BURNING SMELL FROM THE PROGRAMMER AS REPORTED FROM THE FIELD. THIS ANOMALY ALSO CAUSED BOOT-UP ISSUES WITH THE PROGRAMMER. THE COMPONENT WAS REPLACED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER WAS RECEIVED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON BOOTING UP THE PROGRAMMER, THE FIELD REPRESENTATIVE COULD SMELL ELECTRICAL CIRCUITRY BURNING. THE PROGRAMMER WAS UNPLUGGED AND WAS LEFT ABOUT AN HOUR TO ENSURE THERE WAS NO BURNING. THERE WERE NO FLAMES NOTED AND NO REPORTED INJURY TO THE FIELD REPRESENTATIVE. THE PROGRAMMER WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309178 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1