BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDT LAN

    MDR report key: 908907 · Received September 7, 2007

    Report

    Report Number
    2124823-2007-00061
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    August 8, 2007
    Report Date
    September 7, 2007
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K891104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED A SERIES OF ASYSTOLE EVENTS AND THE SYSTEM DID NOT PROVIDE ANY ALARMS. THERE WAS NO REPORTED PT DEATH OR INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDT LAN ECG TELEMETRY SYSTEM MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR