BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SERVER

    MDR report key: 2844374 · Received November 5, 2012

    Report

    Report Number
    2124823-2012-00153
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K032369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCOPE OF THIS INVESTIGATION IS BASED UPON THE INFO GATHERED BY THE GE FIELD ENGINEER (FE). THE ONLINE FE DETERMINED THAT THE APEXPRO TELEMETRY SERVER (ATS) CENTRAL PROCESSING UNIT (CPU) FAN FAILED, RESULTING IN A LOSS OF MONITORING. THE CPU FAN WAS REPLACED AND THE ISSUE HAS NOT REOCCURRED. REVIEW OF THE SERVICE HISTORY OF THE ATS WHICH IS 5 YEARS OLD SHOWED THAT THE CPU FAN HAS NEVER BEEN REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE SHUT DOWN AND LOST TELEMETRY MONITORING FOT TWO HOURS EFFECTING TWELVE PTS DURING THIS TIME. ALTERNATE PT MONITORING WAS NOT OTHERWISE AVAILABLE. THERE WAS NO REPORTED PT 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