BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3043209 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03207
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 25, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE UNIT WAS THOROUGHLY INSPECTED AND ANALYZED. A UNIT BOOT FAIL WITH A BURNT SMELL WAS NOTED. THE DEFECTIVE COMPONENT OF THE UNIT WAS IDENTIFIED AND REPLACED. THE UNIT THEN PASSED ALL FURTHER TESTING AND REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER WOULD NOT START UP. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THEY COULD SMELL SOMETHING BURNING AT THE BACK OF THE UNIT. THE UNIT WAS RETURNED FOR ANALYSIS. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147040 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1