E-Z LIFT BEACH CHAIR

Additional Manufacturer Narrative

FOLLOWING THE REPORTED EVENT, A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE E-Z LIFT BEACH CHAIR AND 4085 SURGICAL TABLE. THE TECHNICIAN FOUND NO ISSUE WITH THE FUNCTION OR OPERATION OF THE BEACH CHAIR OR SURGICAL TABLE; NO REPAIRS WERE REQUIRED. THROUGH FOLLOW-UP WITH FACILITY PERSONNEL, THE TECHNICIAN LEARNED THAT THE BEACH CHAIR HAD BEEN IMPROPERLY INSTALLED BY USER FACILITY PERSONNEL AS THE CLAMPS WERE NOT ENGAGED UPON THE TABLE SIDE RAILS FAR ENOUGH FOR THE THREADED CLAMPS TO PROPERLY ENGAGE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO USER ERROR. THE STERIS 4085 GENERAL SURGICAL TABLE OPERATOR MANUAL STATES IN THE SAFETY PRECAUTIONS SECTION: "WARNING - PERSONAL INJURY HAZARD: WHEN INSTALLING ANY TABLE ACCESSORY, CHECK FOR CORRECT ATTACHMENT AND TIGHTEN SECURELY (IF APPROPRIATE). DO NOT USE A WORN OR DAMAGED ACCESSORY. BEFORE USING ANY ACCESSORY, ENSURE IT HAS BEEN INSTALLED PROPERLY." STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT MEETS OUR REPORTING CRITERIA UNDER 21 CFR PART 803; HOWEVER, STERIS IS NOT THE MANUFACTURER OF THE E-Z LIFT BEACH CHAIR. STERIS NOTIFIED THE MANUFACTURER, SCHUREMED, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. A STERIS ACCOUNT MANAGER WILL CONDUCT IN-SERVICE TRAINING ON SEPTEMBER 25, 2023, ON PROPER USE AND OPERATION OF THE E-Z LIFT BEACH CHAIR. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A NON-STERIS E-Z LIFT BEACH CHAIR DETACHED FROM THEIR STERIS 4085 SURGICAL TABLE WHILE ADJUSTING THE HEIGHT SUBSEQUENTLY CAUSING THE PATIENT TO FALL OFF THE TABLE. NO REPORT OF INJURY. THE PROCEDURE WAS CANCELLED.