DUAL ARTICULATING HEADREST

Additional Manufacturer Narrative

DURING FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS DETERMINED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT INADVERTENTLY ACTIVATED THE HEADREST TOP TILT FUNCTION WHILE THEIR HAND WAS BETWEEN THE END RAIL AND THE HEADBOARD ON THE DUAL ARTICULATING HEADREST ASSEMBLY. STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND HANDLING OF THE DUAL ARTICULATING HEADREST ASSEMBLY HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

FOLLOWING THE REPORTED EVENT, USER FACILITY PERSONNEL REMOVED THE HEAD REST FROM SERVICE. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE'S FINGERS BECAME STUCK BETWEEN THE RAIL AND HEAD REST WHEN HE "GRABBED" THE DEVICE TO BE UTILIZED WITH A SURGICAL TABLE. THE EMPLOYEE SOUGHT MEDICAL TREATMENT HOWEVER, IT IS UNKNOWN WHAT TYPE OF TREATMENT WAS RECEIVED.