BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SYSTEM

    MDR report key: 2043337 · Received February 25, 2011

    Report

    Report Number
    2124823-2011-00021
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K033365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF MONITORING OCCURRED FOR 11 PATIENTS WHEN AN APEX PRO TELEMETRY SYSTEM EXPERIENCED A LOSS OF FUNCTION DUE TO A PRESUMED HARDWARE FAILURE. TELEMETRY MONITORING WAS UNAVAILABLE FOR APPROXIMATELY 2 TO 3 HOURS. ALTERNATE MONITORING WAS NOT AVAILABLE. THERE WERE NO PATIENT INJURIES REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BY 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