BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS 4085 SURGICAL TABLE

    MDR report key: 10337795 · Received July 29, 2020

    Report

    Report Number
    10337795
    Date Received
    July 29, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 23, 2020
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN ELECTRICAL BURNING SMELL IN OPERATING ROOM (OR) AT THE END OF THE CASE, WHILE THE PATIENT WAS STILL ON THE OPERATING ROOM TABLE. WE UNPLUGGED AND REMOVED ALL EQUIPMENT WITH THE EXCEPTION OF THE OPERATING ROOM TABLE AND ANESTHESIA MACHINE. WHEN PATIENT LEFT THE OPERATING ROOM, WE REMOVED THE OPERATING ROOM TABLE AND SMELLED THE BURNING FROM THERE. TABLE BROUGHT TO BIOMED. NO PATIENT HARM. FOLLOWING EVENT, BIOMED: NO ISSUES WERE FOUND WITH ELECTRICAL COMPONENTS. ELECTRICAL SAFETY TEST WAS PERFORMED LEAKAGE TEST AND RESISTANCE TEST ALL PASSED. PERFORMED FUNCTIONAL TEST OF OPERATING ROOM TABLE AND NO BURNING SMELL OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805858 STERIS 4085 SURGICAL TABLE SURGICAL TABLES FQO STERIS CORPORATION 4085

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA