BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080-R SURGICAL TABLE

    MDR report key: 8312438 · Received February 6, 2019

    Report

    Report Number
    1043572-2019-00015
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    May 7, 2018
    Report Date
    February 6, 2019
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) 2018. STERIS WAS NOT MADE AWARE OF THIS EVENT UNTIL RECEIPT OF MEDWATCH ON (B)(6) 2019; 8 MONTHS AFTER THE EVENT OCCURRED. A STERIS SERVICE TECHNICIAN WENT ONSITE ON (B)(6) 2019 TO INSPECTED THE SURGICAL TABLE AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE TABLE WERE IDENTIFIED. PER THE TECHNICIAN'S DISCUSSION WITH USER FACILITY PERSONNEL, THEY CONFIRMED THAT BACK IN (B)(6) 2018, AFTER THE PATIENT WAS GIVEN ANESTHESIA, THEY ATTEMPTED TO PUT THE TABLE IN TRENDELENBURG POSITION. THE TABLE STOPPED MOVING AT A CERTAIN POINT PRIOR TO REACHING FULL TRENDELENBURG POSITION. THE EMPLOYEE CONTINUED TO HOLD THE BUTTON ON THE HAND CONTROL DOWN AND HEARD A "POP" NOISE ON THE TABLE. THE TABLE THEN MOVED THE REST OF THE WAY INTO TRENDELENBURG POSITION. AFTER THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THE USER FACILITY'S BIOMED INSPECTED THE TABLE AND FOUND THAT THE PLASTIC SHROUD ASSEMBLY WAS CRACKED. THE BIOMED REPLACED THE CRACKED ASSEMBLY AND RETURNED THE UNIT TO SERVICE. THE 3080-R SURGICAL TABLE WAS INSTALLED IN (B)(6) 2011 MAKING THE TABLE APPROXIMATELY 7 YEARS OLD AT THE TIME OF THE REPORTED EVEN AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE FACILITY'S BIOMED IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE USER FACILITY CONFIRMED THERE HAVE BEEN NO ADDITIONAL ISSUES WITH THE TABLE SINCE REPAIRS WERE MADE IN 2018.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR 3080-R SURGICAL TABLE WOULD NOT MOVE INTO THE DESIRED POSITION. NO REPORT OF INJURY OR PROCEDURE DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REFERENCE MEDWATCH REPORT MW5082193.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103548 3080-R SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1