BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2240859 · Received August 16, 2011

    Report

    Report Number
    2124823-2011-00138
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF TELEMETRY MONITORING OCCURRED FOR 6 PTS FOR APPROX 2.5 HOURS DUE TO A PRESUMED HARDWARE FAILURE. THE PTS WERE MONITORED VISUALLY BY NURSING STAFF, BUT NO ALTERNATIVE PHYSIOLOGICAL MONITORING WAS AVAILABLE. THERE WERE NO PT INJURIES REPORTED. GE HEALTHCARE'S INVESTIGATION IN THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1