BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SYSTEM

    MDR report key: 1915274 · Received November 2, 2010

    Report

    Report Number
    2124823-2010-00115
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 2, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K033365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF MONITORING OCCURRED FOR APPROXIMATELY 12-15 TELEMETRY PTS WHEN THE APEX PRO TELEMETRY SYSTEM "LOCKED-UP" DUE TO A PRESUMED HARD DRIVE FAILURE. MONITORING WAS UNAVAILABLE FOR APPROXIMATELY 1.5 TO 2 HRS. NO 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 APEXPRO TELEMETRY SYSTEM TELEMETRY MONITORING SYSTEM MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1