BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SYSTEM

    MDR report key: 2053445 · Received March 1, 2011

    Report

    Report Number
    2124823-2011-00020
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K033365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF MONITORING OCCURRED THREE TIMES OVER APPROX TWO WEEKS WHEN AN APEX PRO TELEMETRY SYSTEM EXPERIENCED INTERMITTENT LOSS OF FUNCTION DUE TO A PRESUMED POWER SUPPLY FAILURE. DURING ALL THREE OCCURRENCES THE CRITICAL PTS BEING MONITORED WERE SWITCHED TO AN ALTERNATE TELEMETRY SYSTEM. HOWEVER, 8 PTS WERE NOT MONITORED FOR UP TO ONE HOUR DURING EACH OF THE EVENTS. THERE WERE NO PT INJURIES REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEXPRO TELEMETRY SYSTEM TELEMETRY MONITORING SYSTEM MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1