EV800 ELEVATING TABLE WITH FOUR -WAY FLOAT TOP

Additional Manufacturer Narrative

BASED ON THE IMAGE PROVIDED BY THE CUSTOMER, THE CHAIN ON ONE END OF THE SPROCKET ASSEMBLY APPEARED LOOSE. COMBINED WITH THE PRESENCE OF METAL SHAVINGS, THIS INDICATES THAT THE SPROCKET ON THE TENSION ASSEMBLY SHAFT WAS WORN AND GRINDING AGAINST THE TENSIONER. THIS WEAR LIKELY CAUSED THE DRIVER TO LOOSEN, RESULTING IN THE TEETH SKIPPING ON ONE SIDE AND THE TABLE TO TILT. TS PROVIDED THE FOLLOWING PART NUMBERS: BAR WELDMENT-SPROCKET ADJUST 114-0208G1. SPROCKET ASSEMBLY, 11 TOOTH 112-0262G1. THE DHR FOR THE TABLE WAS REVIEWED AND IT SHOWS THAT THE TABLE WAS FOUND TO BE COMPLIANT PRIOR TO LEAVING DEL MEDICAL. LINE NUMBER 25 OF THE EV800 INSPECTION FORM (MF 10.80) SPECIFICALLY CALLS FOR VERIFYING THE MASTER LINK WAS SECURED AND THAT THE CHAIN HAD PROPER TENSION. THE PROBABILITY OF OCCURRENCE OF HARM FOR ALL RAS ASSOCIATED TO THIS COMPLAINT IS 1 - NEGLIGIBLE, AS DEFINED IN INTERNAL STANDARD OPERATING PROCEDURES.

Description of Event or Problem

ON (B)(6) 2026, THE CUSTOMER CONTACTED TS TO REPORT THAT THE EV 800 TABLETOP (SERIAL NUMBER (B)(6)) TILTED WHILE A PATIENT WAS ON IT. THE CUSTOMER CONFIRMED THAT NO INJURIES OCCURRED AS A RESULT OF THE INCIDENT. PICTURES FROM THE CUSTOMER SHOWED THE SPROCKET ADJUST WORN AND METAL SHAVINGS UNDERNEATH THE TABLETOP, IN A CAVITY NOT ACCESSIBLE TO THE PATIENT OR USER.