BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS / AMSCO

    MDR report key: 2150513 · Received June 22, 2011

    Report

    Report Number
    2150513
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE SETTING UP THE OR FOR A PATIENT PROCEDURE, BOTH THE ANESTHESIOLOGIST AND THE CIRCULATING NURSE NOTED A SMOKE-LIKE SMELL. IT WAS DISCOVERED THAT THE OR TABLE HAD SMOKE COMING OUT FROM THE AC PLUG AT THE BASE OF THE TABLE. A CODE RED WAS IMMEDIATELY CALLED AND FIRE ALARM INITIATED.======================MANUFACTURER RESPONSE FOR OR TABLE, STERIS / AMSCO (PER SITE REPORTER)======================FIELD SERVICE REPRESENTATIVE, WITH THE HELP OF CLINICAL ENGINEERING, CHECKED THIS OR TABLE AND ALL OTHERS FOR ELECTRICAL SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS / AMSCO OR TABLE FQO STERIS CORPORATION 3085 SP *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES