BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SERVER

    MDR report key: 2824323 · Received October 24, 2012

    Report

    Report Number
    2124823-2012-00142
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K032369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION GATHERED BY THE GE FIELD SERVICE ENGINEER (FSE) WILL SERVE AS THE SOURCE OF INFORMATION FOR THIS INVESTIGATION. THE GE FSE RESOLVED THE ISSUE BY REPLACING THE HARD DRIVE. SINCE THE HARD DRIVE WAS REPLACED, THE ISSUE HAS NOT REOCCURRED. REVIEW OF THE SERVICE HISTORY OF THE ATS SERIAL NUMBER INDICATES THE UNIT IS 6 YEARS OLD AND THE HARD DRIVE HAS NOT BEEN REPLACED SINCE THE ORIGINAL INSTALLATION. THE PREVENTATIVE MAINTENANCE RECOMMENDATION IS TO REPLACE THE HARD DRIVE EVERY THREE YEARS, PER THE APEXPRO TELEMETRY SERVER SERVICE MANUAL (2001989-178 REV G) PAGE 4-2. THE OCCUPATION OF INITIAL REPORTER IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE APEXPRO TELEMETRY SERVER (ATS) UNEXPECTEDLY HAD AN INTERRUPTION OF MONITORING. THOUGH IT WAS NOTICED IMMEDIATELY, THREE PATIENTS WERE UNABLE TO BE MONITORED FOR ONE HOUR. NO ALTERNATE MONITORING WAS AVAILABLE. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1