BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2780630 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13202
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS FOUND THE DISPLAY WOULD NOT OPEN DUE TO DAMAGE TO THE REAR HOUSING. ADDITIONALLY, AN INTERNAL COMPONENT WAS FOUND TO HAVE SHORTED AND WAS BURNED. THE FLOPPY DRIVE WAS UNABLE TO READ DISKS. THE FLOPPY CABLE WAS DAMAGED AND THE FLOPPY DRIVE WAS ALSO DAMAGED. THE DAMAGED FLOPPY DRIVE WAS SUSPECTED TO BE CAUSED BY THE INTERNAL SHORT. ALL OTHER DAMAGE TO THE PRODUCT WAS LIKELY CAUSED BY THE UNIT BEING DROPPED. THE PROGRAMMER WAS SUCCESSFULLY REPAIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1