BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 22100842 · Received May 28, 2025

    Report

    Report Number
    1043572-2025-00050
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 28, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    LWG
    UDI-DI
    00724995156596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTRARY TO THE PREVIOUS REPORT THE TABLETOP PAD SETS WERE DISCARDED AND NOT RETURNED TO STERIS FOR EVALUATION. THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL IT WAS DETERMINED THE CAUSE OF THE REPORTED EVENT WAS DUE TO IMPROPER CLEANING AND SET-UP TECHNIQUES WITH THE TABLETOP PAD SETS BY USER FACILITY PERSONNEL. A STERIS ACCOUNT MANAGER CONDUCTED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION TO THE TABLETOP PAD SET, SPECIFICALLY, IN APPROPRIATE CLEANING TECHNIQUES AND INSTALLATION/REMOVAL WITH THE PADS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE TABLETOP PAD SETS SUBJECT OF THE REPORTED EVENTS ARE BEING RETURNED TO STERIS FOR EVALUATION. THE STERIS 5095 SURGICAL TABLE OPERATOR MANUAL STATES, "TO ENSURE PROLONGED USE OF STERIS MATTRESSES AND PADS, ABIDE BY FOLLOWING CLEANING INSTRUCTIONS: INSPECT MATTRESS PRIOR TO AND/OR AFTER USE TO CHECK FOR MATTRESS INTEGRITY. DILUTE ALL CLEANERS, DISINFECTANTS AND GERMICIDES IN ACCORDANCE WITH MANUFACTURERS' INSTRUCTIONS. SOME CLEANING AGENTS LEAVE A RESIDUE WHICH CAN BUILD UP OVER TIME. DEPENDING ON CLEANING AGENT, IT MAY BE NECESSARY TO RINSE AND WIPE CLEAN WITH A SLIGHTLY DAMP CLOTH." THE OPERATOR MANUAL ADDITIONALLY STATES, "TO INSTALL A TABLE PAD, PLACE PAD IN POSITION AND FIRMLY PRESS ASSOCIATED FASTENERS TOGETHER. TO REMOVE A TABLE PAD, GENTLY PEEL OR LIFT THE PAD, AS APPLICABLE, TO FREE IT FROM THE TABLETOP." THE USER FACILITY RECEIVED REPLACEMENT TABLETOP PAD SETS. A STERIS ACCOUNT MANAGER HAS SCHEDULED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION TO THE TABLETOP PAD SET, SPECIFICALLY, IN APPROPRIATE CLEANING TECHNIQUES AND INSTALLATION/REMOVAL WITH THE PADS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THE TABLETOP PAD SETS TO THEIR 5095 SURGICAL TABLES WERE NOT STAYING IN PLACE WHEN THE PATIENT WAS IN TRENDELENBURG. IN ONE OF THE PROCEDURES, THERE WAS A REPORT OF DELAY DUE TO THE PATIENT BEING REPOSITIONED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35261 NA TABLETOP PAD SETS LWG STERIS CORPORATION TABLE PAD 00724995156596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown