BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951986 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00114
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. AS A RESULT THE PRINTED CIRCUIT BOARD WAS CALIBRATED AND THE SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE MISSING STYLUS WAS REPLACED AND CALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO FULLY BOOT UP, THAT IT GOT HUNG UP ON THE SCREEN WITH THE COMPANY LOGO. RUNNING THE SERVICE DISK DID NOT HELP. TECHNICAL SERVICES ALSO RECOMMENDED TO THE CALLER TO TRY REMOVING THE KEYBOARD AND REBOOTING. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57560 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2290 ANALYZER