BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHUREMED POWERED BEACH CHAIR TO 4085 SURGICAL TABLE

    MDR report key: 14026913 · Received April 6, 2022

    Report

    Report Number
    1043572-2022-00025
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    January 10, 2022
    Report Date
    April 6, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GBB
    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

    ON 01/19/2022. THE USER FACILITY CONTACTED A STERIS ACCOUNT MANAGER REQUESTING IN-SERVICE TRAINING ON THEIR 4085 SURGICAL TABLE. WHILE ONSITE TO PERFORM THE TRAINING, THE ACCOUNT MANAGER WAS INFORMED BY USER FACILITY PERSONNEL THAT THEIR SCHUREMED POWERED BEACH CHAIR DETACHED FROM THEIR 4085 SURGICAL TABLE AS THEY WERE REPOSITIONING THE BEACH CHAIR FOR PATIENT TRANSFER. STERIS IS NOT THE MANUFACTURER OF THE SCHUREMED POWERED BEACH CHAIR. THE USER FACILITY NOTIFIED THE MANUFACTURER, SCHUREMED, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. THE ACCOUNT MANAGER EVALUATED THE 4085 SURGICAL TABLE AND FOUND IT TO BE OPERATING PROPERLY. NO REPAIRS WERE REQUIRED, AND THE UNIT WAS RETURNED TO SERVICE. IT WAS DETERMINED THAT THE EVENT WAS ATTRIBUTED TO USER ERROR AS FACILITY PERSONNEL HAD INCORRECTLY SET THE HAND CONTROL TO NORMAL ORIENTATION WHILE THE PATIENT WAS POSITIONED IN REVERSE ORIENTATION. BASED ON THE PATIENT ORIENTATION SELECTED ON THE HAND CONTROL, THE MOVEMENTS OF THE BACK AND LEG SECTION ARE REVERSED. DUE TO THE INCORRECT PATIENT ORIENTATION SELECTED ON THE HAND CONTROL, USER FACILITY INADVERTENTLY RAISED THE LEG SECTION INSTEAD OF THE BACK SECTION CAUSING THE BEACH CHAIR TO DETACH AND THE REPORTED EVENT TO OCCUR. THE 4085 SURGICAL TABLE HAND CONTROL IS EQUIPPED WITH A LED VISUAL INDICATOR FOR NORMAL AND REVERSE PATIENT ORIENTATION SETTING. THE 4085 SURGICAL TABLE OPERATOR MANUAL STATES (4-6), SOME SURGERIES (E.G., SHOULDER) REQUIRE THE PATIENT TO BE IN REVERSE POSITIONING AND THE TABLE TO BE OPERATED IN A REVERSE CONFIGURATION. PRESS REVERSE ORIENTATION BUTTON ON HAND CONTROL AND HOLD FOR TWO SECONDS, YELLOW LED SHOULD LIGHT BESIDE GRAPHIC REPRESENTATION OF REVERSE ORIENTATION. PRESS REVERSE ORIENTATION BUTTON AGAIN AND HOLD FOR TWO SECONDS TO CANCEL REVERSE ORIENTATION FUNCTION AND GREEN LED LIGHTS BESIDE GRAPHIC REPRESENTATION OF NORMAL ORIENTATION. WHEN REVERSE ORIENTATION BUTTON IS PRESSED, ALL OTHER HAND CONTROL COMMANDS (THROUGH THE CONTROL SYSTEM) NOTE THE NEW PATIENT HEAD POSITION. TRENDELENBURG AND LATERAL TILT MOVEMENTS AND BACK AND LEG SECTIONS ARE AUTOMATICALLY REVERSED. THE ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE 4085 SURGICAL TABLE, SPECIFICALLY PROPERLY SETTING THE PATIENT ORIENTATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT NUMBER MW5107483 THAT AT THE END OF A PATIENT PROCEDURE THEIR SCHUREMED POWERED BEACH CHAIR THAT WAS ATTACHED TO A 4085 SURGICAL TABLE DETACHED. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703958 SCHUREMED POWERED BEACH CHAIR TO 4085 SURGICAL TABLE POWERED BEACH CHAIR GBB STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown