BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO

    MDR report key: 3250735 · Received June 20, 2013

    Report

    Report Number
    3250735
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STERIS CORPORATION
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE OR TABLE WAS CHECKED AND WAS FUNCTIONAL PRIOR TO BEGINNING THE CASE. PATIENT MOVED ONTO THE OR TABLE AND, WHEN PATIENT WAS SECURED TO THE TABLE, IT WAS UNLOCKED AND THE TABLE WAS MOVED INTO SURGICAL POSITION. UPON ATTEMPTING TO LOCK THE TABLE AGAIN, THERE APPEARED TO BE NO ELECTRICITY TO THE BED TO LOCK IT. THE PLUG WAS REMOVED AND CHANGED OUT WITH ANOTHER PLUG, STILL COULDN'T LOCK THE BED. THE PLUG WAS THEN PLUGGED INTO DIFFERENT OUTLETS, WITHOUT SUCCESS. THE PATIENT HAD TO BE MOVED TO A DIFFERENT OR TABLE.======================MANUFACTURER RESPONSE FOR OPERATING ROOM SURGICAL TABLE, SURGICAL TABLE (PER SITE REPORTER).======================MANUFACTURER RESPONSE FOR SURGICAL TABLE, SURGICAL TABLE (PER SITE REPORTER).======================NONE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SHOULDER ARTHROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281033 AMSCO TABLE, SURGICAL BWN STERIS CORPORATION * *
    281401 AMSCO TABLE, SURGICAL BWN STERIS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NO OTHER THERAPIES