BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2911388 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15880
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 26, 2012
    Report Date
    May 23, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROGRAMMER WAS PERFORMED. TESTING CONFIRMED THE PRODUCT IS BURNED. THE DAMAGED PIECE WAS REPLACED AND THE UNIT NOT PASSES ALL INCOMING TESTS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER STARTED SMOKING AROUND THE FLOPPY DISK AREA. THE SMOKE SUBSEQUENTLY STOPPED, BUT IT WAS SIGNIFICANTLY SMELLY. THE PROGRAMMER WAS ABLE TO BE RE-STARTED. HOWEVER, IT WILL BE RETURNED FOR TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17363 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1