BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 19229681 · Received May 2, 2024

    Report

    Report Number
    1043572-2024-00026
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 2, 2024
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 3080 SP SURGICAL TABLE SUBJECT OF THE REPORTED EVENT WAS INSTALLED AT THE USER FACILITY IN JANUARY 1994 AND IS APPROXIMATELY 30 YEARS OLD. THE USER FACILITY STATED THAT THE TABLE WAS REMOVED FROM SERVICE FOLLOWING THE REPORTED EVENT. A STERIS TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND FOUND THAT THE TABLE WAS MISSING COMPONENTS. THE TECHNICIAN REPLACED THE OVERRIDE SWITCH ASSEMBLY, FIVE SWITCH BOOTS AND TWO C-CLIPS IN THE FLOOR LOCK ASSEMBLY. FOLLOWING THE REPAIRS, THE TECHNICIAN TESTED THE TABLE AND CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION. THE TABLE WAS NOT RETURNED TO SERVICE PER THE USER FACILITY'S REQUEST DUE TO THE AGE OF THE UNIT. NO ADDITIONAL ISSUES REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR 3080SP SURGICAL TABLE BEGAN TO MOVE INTO TREND ORIENTATION WITHOUT BEING COMMANDED TO DO SO. USER FACILITY PERSONNEL UNPLUGGED THE TABLE AND THE MOVEMENT STOPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY, AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410061 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown