BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIO MESSENGER LLT

    MDR report key: 823517 · Received February 2, 2007

    Report

    Report Number
    1028232-2007-00011
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    December 19, 2006
    Report Date
    January 29, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DSI
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REP PLACED THIS DEVICE IN THE PACU OF HOSP ON THE REQUEST OF DR. THE UNIT WAS POWERED ON AND CONNECTED TO A TELEPHONE LINE. THE HOSP STATES THAT THIS UNIT CAUSED COMMUNICATION PROBLEMS WITH THE COMPUTERS FOR APPROX 45 MINS. PLEASE REFERENCE REG MEDICAL'S MDR 4200070000-2007-8001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIO MESSENGER LLT PACEMAKER MONITOR, TELEMETRY DSI BIOTRONIK GMBH AND CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other
    2
    3