HILL LABORATORIES CO

Additional Manufacturer Narrative

NO COMPLAINT WAS RECEIVED BY HILL LABORATORIES DIRECTLY FROM THE FACILITY, HOWEVER A PARTS ORDER FOR A REPLACEMENT BOARD, AND TILT ACTUATOR WAS RECEIVED FOR THE DEVICE (SERIAL NUMBER: (B)(6) ON 6/19/2025 AND SHIPPED ON 6/24/2025. HILL LABORATORIES REQUESTED A CONTACT NAME AND PHONE NUMBER FROM THE INITIAL REPORTED IN THE MDR AND MADE MULTIPLE ATTEMPTS TO CONTACT THE INDIVIDUAL TO COMPLETE THE INVESTIGATION BUT RECEIVED NO RESPONSE. THE EVENT DESCRIPTION IN MDR REPORT#: MW5171894 LIKELY POINTS TO A LATCHED RELAY IN THE DEVICE'S CIRCUIT BOARD THAT IMPACTED COMMUNICATION BETWEEN THE FOOT PEDAL AND THE LIFTBACK / TILT ACTUATOR. WITH THE RELAY LIKELY LATCHED, THE TILT ACTUATOR LIKELY KEPT RUNNING - CAUSING THE TABLE TO TILT PATIENT INTO REVERSE TRENDELENBERG POSITION, THE SMELL OF BURNING ELECTRIC PARTS AND SUBSEQUENT TISSUE INJURY BY THE STAFF WHEN ATTEMPTING TO SECURE THE PATIENT. ALTHOUGH COMPONENT MALFUNCTIONS CAN OCCUR, THIS TYPE OF MALFUNCTION IS RARE. USUALLY, THE TILT MOTOR DOES NOT MOVE ONCE A RELAY IS LATCHED. DATA ANALYSIS NOTED AN INCREASE IN RELAY ISSUES STARTING IN 2023. A NEW BOARD VERSION WAS INITIATED IN 2024 AND THEN APPROVED BY THE ENGINEERING TEAM IN 2025 WHICH ADDRESSES THE LATCHED RELAY. THE CUSTOMER RECEIVED THE LATEST VERSION BOARD. A SEATBELT OPTION EXISTS FOR THIS DEVICE BUT WAS NOT PURCHASED BY THE CUSTOMER IN 2017. HILL LABORATORIES IS INITIATING A REVIEW OF THIS OPTION WITH THE INTENT OF MAKING THE SEATBELT A STANDARD FEATURE ALONG WITH REVISED INSTRUCTIONS IN THE USER MANUAL.

Description of Event or Problem

FOLLOWING PATIENT TREATMENT, STAFF ATTEMPTED TO REPOSITION THE BED TO BRING INTO STANDARD PRONE POSITION. THE BED HAD NO ELECTRIC RESPONSE TO FOOT CONTROLS BUT CONTINUED TO TILT PATIENT INTO REVERSE TRENDELENBURG POSITION. STAFF WAS ABLE TO SECURE PATIENT AND ASSIST TO STANDING POSITION WITHOUT PATIENT INJURY HOWEVER THE PHYSICIAN WAS INJURED WHILE PROTECTING THE PATIENT FROM A FALL. THE MOTOR WAS NOTED TO CONTINUE TO RUN AND SMELLED OF BURNING ELECTRIC PARTS.