BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2788856 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03569
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 30, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) SYSTEM ERRORS FOUND IN THE PROGRAMMER ERROR LOG. THE SYSTEM FAN IS NOISY. (B)(4) ANALYZER WAS SYSTEMS TESTED WITH NO FAULT FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO PRINT FROM THE ANALYZER A MESSAGE APPEARED "PRINT QUE FULL" AND THE ANALYZER LOCKED AND THE ANALYZER SCREEN COULD NOT BE ACCESSED. RECYCLING THE POWER RESTORED ACCESS TO THE ANALYZER. CLEARING THE PRINT QUE DID NOT RESOLVE THE ISSUE. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO PRINT FROM THE ANALYZER A MESSAGE APPEARED "PRINT QUE FULL" AND THE ANALYZER LOCKED AND THE ANALYZER SCREEN COULD NOT BE ACCESSED. RECYCLING THE POWER RESTORED ACCESS TO THE ANALYZER. CLEARING THE PRINT QUE DID NOT RESOLVE THE ISSUE. THE PROGRAMMER AND ANALYZER WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other