BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5085 SURGICAL TABLE

    MDR report key: 17003663 · Received May 25, 2023

    Report

    Report Number
    1043572-2023-00110
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    August 19, 2019
    Report Date
    May 25, 2023
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    UDI-DI
    00724995154905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT WAS (B)(6) 2019, NOT (B)(6) 2019. THIS WAS A TYPOGRAPHICAL ERROR IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, STERIS WAS CONTACTED BY THE CUSTOMER IN REGARD TO THEIR SERVICE NEEDS FOR THEIR 5085 SURGICAL TABLE TILTING. THE SAME DAY, A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND FOUND IT TO BE OPERATING PROPERLY; NO REPAIRS WERE REQUIRED. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED TILTING AND THE TABLE WAS RETURNED TO SERVICE. AT THAT TIME, STERIS WAS NOT INFORMED OF ANY PATIENT INVOLVEMENT RELATED TO THE SERVICE REQUEST. ON (B)(6) 2023, STERIS RECEIVED THE USER FACILITY MEDWATCH SUBJECT OF THIS EVENT WHICH WAS OUR FIRST AWARENESS OF THE ADVERSE INCIDENT. BASED ON THE TECHNICIAN'S INSPECTION AND THE DESCRIPTION OF THE EVENT, STERIS WAS UNABLE TO DUPLICATE OR DETERMINE A CAUSE OF THE REPORTED EVENT. HOWEVER, IT IS LIKELY THAT USER FACILITY PERSONNEL INADVERTENTLY ACTIVATED THE TILT COMMAND ON THE TABLE HAND CONTROL RESULTING IN THE REPORTED EVENT. THE TABLE SUBJECT OF THE EVENT IS UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. STERIS HAS CONTINUED TO PERFORM BIANNUAL PREVENTIVE MAINTENANCE VISITS FOR THE TABLE SINCE THE REPORTED EVENT. THE MOST RECENT PREVENTIVE MAINTENANCE VISIT WAS COMPLETED ON (B)(6) 2023; FOLLOWING THE VISIT THE TABLE WAS TESTED AND CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH # THAT DURING A PATIENT PROCEDURE THEIR 5085 SURGICAL TABLE UNEXPECTEDLY ROTATED LEFT WITHOUT BEING COMMANDED TO DO SO. THE PATIENT WAS CAUGHT BY USER FACILITY PERSONNEL AND EASED DOWN TO THE FLOOR WITHOUT ANY IMPACT. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562925 5085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE 00724995154905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown