BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 897405 · Received August 14, 2007

    Report

    Report Number
    1220063-2007-00023
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    July 8, 2007
    Report Date
    August 13, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRG
    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 INDICATING THAT AN INCIDENT OCCURRED INVOLVING AN ACCESSORY PRODUCT, (PATIENT MONITOR WALL MOUNTING BRACKET) THAT BROKE AND FELL TO THE FLOOR WITH A PATIENT MONITOR ATTACHED. NO PATIENT INJURY WAS REPORTED. WE HAVE REQUESTED THE RETURN OF THE CITED PATIENT MONITOR AND WALL MOUNTING BRACKET ACCESSORY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PATIENT MONITOR WALL MOUNTING BRACKET DRG DRAEGER MEDICAL SYSTEMS, INC. NOT INDICATED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR