BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3090 SP SURGICAL TABLE

    MDR report key: 15329150 · Received August 31, 2022

    Report

    Report Number
    1043572-2022-00058
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 31, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND HYDRAULIC OIL IN THE BOTTOM OF THE TABLE BASE AND THE HYDRAULIC OIL LEVEL TO BE LOW. THE TECHNICIAN ADDED HYDRAULIC OIL, TESTED THE TABLE, AND FOUND IT TO BE OPERATING PROPERLY. A FEW DAYS FOLLOWING THE TECHNICIAN'S INITIAL INSPECTION, HE PERFORMED PREVENTIVE MAINTENANCE AND CONFIRMED THE TABLE TO BE OPERATING TO SPECIFICATIONS. THE SURGICAL TABLE WAS RETURNED TO SERVICE. THE 3080SP SUBJECT OF THE REPORTED EVENT IS APPROXIMATELY 28 YEARS OLD AND IS SERVICED AND MAINTAINED BY THE USER FACILITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE AN EMPLOYEE COMMANDED THEIR 3080SP SURGICAL TABLE TO RAISE IN HEIGHT HOWEVER, THE TABLE "SHUTTERED" IN A DOWNWARD MOVEMENT AND MADE A "LOUD NOISE". THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305344 3090 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown