BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SERVER

    MDR report key: 2844407 · Received November 5, 2012

    Report

    Report Number
    2124823-2012-00152
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K032369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCOPE OF THIS INVESTIGATION IS BASED UPON THE INFO OBTAINED FROM THE FIELD ENGINEER (FE). AFTER ARRIVING ONSITE, THE FE FOUND THAT THE APEXPRO TELEMETRY SERVER (ATS) HAD SHUT DOWN. AFTER POWERING THE UNIT BACK UP, THE FE RAN THE WEBMIN DIAGNOSTICS AND NOTED THAT THE CENTRAL PROCESSING UNIT (CPU) FAN WAS NOT OPERATING. A REPLACEMENT CPU FAN WAS INSTALLED IN THE UNIT ON (B)(4) 2012. THE FE CONFIRMED THAT THE ATS IS NOW BACK ONLINE AND FUNCTIONING NORMALLY AND THE USER IS ABLE TO ADMIT PTS TO THE SYSTEM. REVIEW OF THE SERVICE HISTORY OF THE ATS SHOWED THAT THE CPU FAN HAS NOT BEEN REPLACED SINCE THE UNIT WAS INSTALLED APPROX FOUR YEARS AGO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLINICAL INFO CENTER SHUT DOWN DUE TO AN ISSUE WITH THE APEXPRO TELEMETRY SERVER (ATS) FAN FAILURE. THIS CAUSED LOSS OF MONITORING FOR THIRTY MINUTES AFFECTING FIVE PTS UNTIL ALTERNATE ATS MONITORING WAS ESTABLISHED. 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