BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 892909 · Received August 9, 2007

    Report

    Report Number
    1220063-2007-00021
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 10, 2007
    Report Date
    August 9, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM OUR LOCAL OFFICE OF A POSSIBLE PRODUCT PROBLEM INVOLVING OUR UNIVERSAL BED MOUNT DEVICE. A CUSTOMER HAS REPORTED THAT DURING THE TRANSPORT OF A PATIENT FROM OR TO ICU THE UNIVERSAL BED MOUNT THAT WAS ATTACHED TO A PATIENT'S BED FELL APART. IT WAS ALSO INDICATED THAT A DRAEGER PATIENT MONITOR THAT WAS CONNECTED TO THE BED MOUNT FELL TO THE FLOOR AND WAS DAMAGED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. 5188813 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR