BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAM

    MDR report key: 1063599 · Received June 20, 2008

    Report

    Report Number
    2124823-2008-00054
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 20, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K011000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAC 4A WITH TRAM MODULE AND MOUNT ARM DISENGAGED FROM THE VERTICAL WALL MOUNT AND FELL WHILE A NURSE WAS RAISING THE BED. THE MOUNTS WERE LOCATED DIRECTLY OVER PATIENT'S BED DUE TO BED AREA AND AVAILABLE WALL SPACE LOGISTICS. NO PATIENT INJURY WAS REPORTED. 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 TRAM PHYSIOLOGIC PATIENT MONITOR MHX GE HEALTHCARE 416537-006

    Patients

    Seq Age Sex Outcome Treatment
    1