BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3213667 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-07946
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE PROGRAMMER WAS OUT OF SPECIFICATIONS DUE TO BURNT DAMAGE IN THE PART. THE INSULATOR WAS REPLACED BECAUSE IT WAS MELTED. THIS PROGRAMMER WAS DEFECTIVE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER WAS RETURNED BECAUSE AS PER FIELD REPRESENTATIVE WHEN TRIED TO POWER UP THE PROGRAMMER IT SMELLED LIKE SOMETHING WAS BURNING. THE FIELD REPRESENTATIVE TURNED IT OFF AND WENT TO ANOTHER ROOM; TRIED SMELLING THE PROGRAMMER BUT THE SAME SCENT WAS SMELLED. HOWEVER, THE PROGRAMMER WAS NOT HOT TO TOUCH. ALSO, WHEN USING THIS PROGRAMMER THERE WAS LOTS OF NOISE NOTED ON THE ELECTROCARDIOGRAM. THIS PROGRAMMER WAS RETURNED FOR ANALYSIS AND NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313200 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1