BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SYSTEM

    MDR report key: 2013561 · Received February 3, 2011

    Report

    Report Number
    2124823-2011-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 3, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K033365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF MONITORING OCCURRED FOR MULTIPLE (UP TO 16) PTS WHEN THE APEX PRO TELEMETRY SYSTEM EXPERIENCED INTERMITTENT LOSS OF TELEMETRY FOR PERIODS AS LONG AS 10 MINS. ALTERNATE MONITORING WAS NOT OTHERWISE AVAILABLE. THE ISSUE WAS DETERMINED TO BE A NETWORK INFRASTRUCTURE PROBLEM ASSOCIATED WITH THE ENTERPRISE ACCESS SUB-SYSTEM. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE 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