BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEXPRO TELEMETRY SYSTEM

    MDR report key: 2102224 · Received May 19, 2011

    Report

    Report Number
    2124823-2011-00070
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K033365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF MONITORING ON 12 TELEMETRY PATIENTS FOR A PERIOD OF 2 HOURS. NO REPORTED PATIENT INJURY OR DEATH. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE 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