BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE TELEMETRY SERVER

    MDR report key: 2913341 · Received January 8, 2013

    Report

    Report Number
    2124823-2013-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K080251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CARESCAPE TELEMETRY SERVER SHUT DOWN AND WOULD NOT POWER BACK UP, LOSING TELEMETRY MONITORING FOR 45 MINUTES AFFECTING FIFTEEN PTS. 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
    10333 CARESCAPE TELEMETRY SERVER TELEMETRY MONITORING SYSTEM MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1