BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO STERIS

    MDR report key: 1342251 · Received March 4, 2009

    Report

    Report Number
    1342251
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 4, 2009
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SPINAL FUSION, STAFF MOVED C ARM INTO POSITION AROUND OR TABLE. SURGEON WAS STILL INVOLVED WITH PATIENT AND NOTICED PORTION OF TABLE DROP. PATIENT WAS REASSESSED AND SURGERY CONTINUED. POSSIBILITY OF PATIENT LINE RUNNING ACROSS AUXILIARY BED CONTROL SWITCHES. THE PROTECTIVE COVER FOR THESE SWITCHES WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO STERIS TABLE, OR FQO STERIS CORPORATION 3080RL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR