BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPLORER 2200 DIGITAL RADIOGRAPHY SYSTEM

    MDR report key: 2594438 · Received December 9, 2010

    Report

    Report Number
    9616853-2010-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 8, 2010
    Manufacturer
    IMAGING DYNAMICS COMPANY (IDC)
    Product Code
    KPR
    PMA / PMN Number
    K063039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A RADIOLOGY TECHNICIAN WAS PREPARING A PT FOR AN X-RAY BY HAVING THEM LAY ON XPLORER 2200 SYSTEM TABLE. WHEN THE PT LAY DOWN ON THE TABLE, THE LEG AT THE HEAD OF THE TABLE COLLAPSED IN A DOWNWARD POSITION, CAUSING THE TABLE TO HIT THE IMAGE DETECTOR THAT WAS SITUATED UNDER THE TABLE. THE PT WAS SUBSEQUENTLY REMOVED FROM THE TABLE. THERE WAS NO INJURY TO EITHER THE PT OR A HEALTH CARE WORKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPLORER 2200 DIGITAL RADIOGRAPHY SYSTEM XPLORER 2200 KPR IMAGING DYNAMICS COMPANY (IDC) XPLORER 2200

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR