BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 5515921 · Received March 22, 2016

    Report

    Report Number
    5515921
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 11, 2016
    Manufacturer
    SIEMENS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECENT HISTORY OF MONITOR SUSPENSION ARM (BOOM) FAILURE AT ANOTHER HOSPITAL IN CA. SUPPORTED MONITORS AND SUSPENSION ARM WERE FOUND ON THE FLOOR AT THAT HOSPITAL BUT NO PERSONNEL OR PATIENTS WERE PRESENT AT THE TIME. CORPORATE IDENTIFIED THAT THE SAME EQUIPMENT EXISTS AT SEVERAL OTHER HOSPITALS, INCLUDING THIS ONE. THEY REQUESTED THAT A MEDSUN REPORT BE ENTERED, REPORTEDLY FROM AN INADEQUATE RESPONSE BY THE VENDOR. IT WAS ALSO REPORTED THAT NEITHER SIEMENS OR MAVIG WILL BE INSPECTING THIS EQUIPMENT. MANUFACTURER RESPONSE FOR SUSPENSION ARM (BOOM), (BRAND NOT PROVIDED) (PER SITE REPORTER): NOTIFIED BY HOSPITAL SYSTEM CORPORATE PERSONNEL - NEITHER SIEMENS OR MAVIG WILL BE INSPECTING THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174161 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA SIEMENS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO