BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC MONITOR

    MDR report key: 4100707 · Received May 21, 2014

    Report

    Report Number
    4100707
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HILL-ROM
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    UPON RETURNING FROM LUNCH AT THIS TIME, RN INFORMED UNIT THAT THIS PATIENT HAD THE CARDIAC MONITOR FALL ONTO THE BED AND HIT THE PATIENT'S HEAD. PER RN, THE ULTRASOUND TECH WAS IN THE ROOM AND GETTING READY TO PERFORM RENAL US AND RRT WAS HELPING REPOSITION THE BOOM IN THE PATIENT'S ROOM. AFTER RRT LEFT THE ROOM AND THE BED WAS RAISED BY THE US TECH. A CALL FOR HELP WAS HEARD BY RN AND THE PATIENT'S CARDIAC MONITOR WAS IN THE PATIENT'S BED. PT WAS ASSESSED BY RN AND DOCTOR. NO INJURY NOTED AT THIS TIME FROM RN OR DOCTOR. ICE PLACED TO PATIENT'S HEAD. RN TO CONTINUE TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302168 CARDIAC MONITOR MONITOR, CARDIAC DRT HILL-ROM P662A *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR