E-Z LIFT BEACH CHAIR

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR NON-STERIS E-Z LIFT BEACH CHAIR WHICH WAS ATTACHED TO A STERIS SURGICAL TABLE FELL BACKWARDS RESULTING IN A PROCEDURE DELAY AND INJURY TO THE PATIENT'S NECK. IT IS UNKNOW IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

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. THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR A FULL ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. SCHUREMED'S EVALUATION DETERMINED THAT THE SLIDE EXTENDERS REQUIRED TO BE REPLACED DUE TO THE DAMAGE THAT WAS CAUSED BY MIS-CLAMPING THE CHAIR TO THE TABLE BY USER FACILITY PERSONNEL. A STERIS SALES REPRESENTATIVE PROVIDED IN-SERVICE TRAINING TO THE USER FACILITY ON PROPERLY ATTACHING THE CHAIR TO THE TABLE ACCORDING TO THE IFU TO PREVENT ANY DAMAGE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.