BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2781014 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12948
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    January 11, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROGRAMMER IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE, OR IF FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE PROGRAMMER WOULD NOT BOOT UP. DETAILED TESTING FOUND A DAMAGED COMPONENT ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (PCB). TWO PCBS WERE EXCHANGED, AND THE FLOPPY DISK DRIVE WAS ALSO REPLACED BECAUSE PARTS OF A FLOPPY DISK WERE STUCK IN THE DRIVE. AFTER THE REPAIR, THE PROGRAMMER WAS FUNCTIONAL AGAIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER EMITTED SMOKE AFTER IT WAS USED. AFTERWARD, IT COULD NO LONGER BE TURNED ON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM KRG CPI PLANT - ST. PAUL 3120

    Patients

    Seq Age Sex Outcome Treatment
    1