TYPE-S OVERLAY

Description of Event or Problem

ONE THERAPIST WAS IN THE ROOM AND WAS AT THE FOOT END OF THE TABLE. WHEN PT WENT TO LAY DOWN THEY WENT BACK REALLY FAST CAUSING THE BOARD TO POP OFF THE LOK-BAR AND FROM THERE THE BOARD AND COUCHTOP RUBBED TOGETHER AND THE BOARD SLID RIGHT OF THE END OF THE TABLE. THE PT FELL BACK HEAD FIRST, BUMPED THEIR HEAD. BOARD WAS INITIALLY LOCKED DOWN WITH THE LOK-BAR AND THE VELCRO STRAP BUT NOT SURE IF THE STRAP WAS TIED TIGHT AS IT SHOULD BE. HOSPITAL REPORTED PT WAS NEGATIVE FOR A CONCUSSION AND BLURRED VISION. FOUR PLAIN VIEW X-RAYS OF THE RIGHT SHOULDER WERE TAKEN SHOWING A SHOULDER SPRAIN, TORN LIGAMENTS, AND A SMALL AC SEPARATION. PT GIVEN A SLING AND INSTRUCTED TO WEAR FOR 2 DAYS ALLOWING SHOULDER TO HEAL IF PROTECTED. PT WAS NOT GIVEN ANY ADDITIONAL PAIN MEDS AS HE HAS A PRESCRIPTION FROM THE RADIATION DEPARTMENT FOR ROXANOL.

Additional Manufacturer Narrative

THE BELT WAS NOT PROPERLY USED TO SECURE THE OVERLAY TO THE TABLE. DEVICE WAS NOT AVAILABLE FOR EVAL. REVIEWING CLINICIAN'S DESCRIPTION OF EVENT AND MEDICAL DEVICE REPORT FILED WITH FDA BY THE CLINIC, IT WAS DETERMINED THAT THE DEVICE WAS USED AGAINST THE PROVIDED INSTRUCTION FOR USE. THE INSTRUCTION PROVIDED WITH THE DEVICE CONTAINED WARNINGS TO: NOT ALLOW THE PT TO REPOSITION THEMSELF. DO NOT USE THE LOK-BAR TO SECURE POSITIONING DEVICES. A NOTE ON THE BOARD ALSO INSTRUCTS "ATTACH OVERLAY TO TABLE USING STRAP BEFORE POSITIONING THE PT". NO ADDITIONAL ACTION PLANNED. DEVICE NOT USED AS INTENDED. CLINIC CONFIRMED THAT THEY WILL NOT EXTEND THE OVERLAY AND PROVIDE PICTURES OF THEIR FUTURE SETUP/USE. INITIAL INFO PROVIDED BY USER DID NOT MEET REQUIREMENTS OF A MEDICAL DEVICE REPORTING INCIDENT. ADDITIONAL INFO PROVIDED ON 10/10/2008 VIA MEDWATCH FORM INITIATED BY SER AND EMAIL INFO PROVIDED BY USER ON 10/17/08 DETAILED ASSESSMENT OF INJURIES.