BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 19087811 · Received April 11, 2024

    Report

    Report Number
    1043572-2024-00021
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 11, 2024
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE TABLE AND OBSERVED A BUILDUP OF RUST AROUND THE TABLE'S CASTERS WHICH MADE THE TABLE DIFFICULT TO MOVE. WHILE ONSITE THE TECHNICIAN REPLACED ALL FOUR OF THE SURGICAL TABLE'S CASTERS, TESTED THE SURGICAL TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE TECHNICIAN COUNSELED THE USER FACILITY REGARDING A PREVENTIVE MAINTENANCE PROGRAM TO ENSURE ROUTINE CHECKS FOR DAMAGED OR WORN PARTS. THE TABLE WAS MANUFACTURED IN 1997 AND IS 27 YEARS OLD. THE SURGICAL TABLE IS NOT UNDER STERIS SERVICE CONTRACT FOR MAINTENANCE. IT IS UNKNOWN WHO IS RESPONSIBLE FOR COMPLETING PREVENTIVE MAINTENANCE ACTIVITIES FOR THE SURGICAL TABLE SUBJECT OF THE EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE TABLE AND OBSERVED A BUILDUP OF RUST AROUND THE TABLE'S CASTERS WHICH MADE THE TABLE DIFFICULT TO MOVE. WHILE ONSITE THE TECHNICIAN REPLACED ALL FOUR OF THE SURGICAL TABLE'S CASTERS, TESTED THE SURGICAL TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE TABLE WAS MANUFACTURED IN 1997 AND IS 27 YEARS OLD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN EMPLOYEE STRAINED HIS BACK AND SHOULDER WHILE MOVING A 3080 SP SURGICAL TABLE. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683354 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown