BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1051474 · Received May 21, 2008

    Report

    Report Number
    2124823-2008-00051
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 21, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DRT
    PMA / PMN Number
    K053356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF AUDIBLE ALARMS AT MULTIPLE CIC'S SUPPORTING TELEMETRY PTS. NO PT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER WIRELESS SYSTEMS DRT GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1