BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 RL SURGICAL TABLE

    MDR report key: 14187583 · Received April 22, 2022

    Report

    Report Number
    1043572-2022-00033
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Report Date
    April 22, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLE AND FOUND THAT THE THAT THE FLOOR LOCK LINKAGE REQUIRED REPLACEMENT. THIS CAUSED THE TABLE TO INTERMITTENTLY UNLOCK RESULTING IN THE REPORTED EVENTS. THE TABLE SUBJECT OF THE EVENT WAS INSTALLED IN 1993 MAKING IT APPROXIMATELY (B)(6)AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE AMSCO 3080 RL SURGICAL TABLE EQUIPMENT MANUAL STATES IN THE PREVENTIVE MAINTENANCE (129361-861), "CASTERS AND FLOOR LOCKS. CLEAN AND INSPECT CASTERS 2X YEAR. CHECK FLOOR-LOCK MECHANISM FOR PROPER OPERATION 2X YEAR." THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    CONTRARY TO THE PREVIOUS REPORT THAT WAS SUBMITTED, STERIS PROVIDED IN-SERVICE TRAINING ON THE PROPER PREVENTIVE MAINTENANCE ACTIVITIES FOR THE 3080 RL SURGICAL TABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    STERIS OFFERED AN IN-SERVICE TRAINING ON THE PROPER PREVENTATIVE MAINTENANCE ACTIVITIES FOR THE 3080 RL SURGICAL TABLE, HOWEVER THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR 3080 RL SURGICAL TABLE HAS BEEN INTERMITTENTLY UNLOCKING. USER FACILITY PERSONNEL RE-LOCKED THE TABLE IN EACH CASE AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127889 3080 RL SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown