BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2170269 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09368
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE (B)(4) LABORATORY, ANALYSIS CONFIRMED THE TOUCHSCREEN ISSUE. SEVERAL DENTS WERE NOTED ON THE TOUCHSCREEN, INDICATING THE DAMAGE WAS LIKELY INDUCED. THE TOUCHSCREEN WAS EXCHANGED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER DISPLAYED A TOUCHSCREEN ISSUE. IN ADDITION, TELEMETRY WAS UNABLE TO BE ESTABLISHED. THIS DEVICE WAS RETURNED FOR REPAIR.

    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