MED-TEC, TYPE-S SYSTEM
Received Jul 22, 2003 · Event occurred Jul 15, 2003
Report 1932738-2003-00001 · MDR key 485134
Device
Generic name
Carbon Fiber Head, Neck, And Shoulder Base
Manufacturer
Med-tec,inc.Model number
MT-CFHN-SUB2Catalog number
MT-CFHN-SUB2
Lot number
NA
Product problems
- Fail-Safe Design Failure
Patient
*
- Fall
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A PT WAS SET UP ON THE TYPE-S ON THE VARIAN EXACT COUCH. THE EXACT-BAR IS PERMANENTLY ATTACHED TO THE TYPE-S AND IT WAS ATTACHED TO THE TABLE. THE THERAPIST PUSHED ON THE EXACT-BAR TO MAKE SURE IT WAS SECURE. THE PT LAID DOWN ON THE TYPE-S, BUT PT WAS TOO HIGH, SO THEY ASKED PT TO MOVE DOWN SO THEY COULD GET THE MASK ON. WHEN PT DID THAT, PT AND THE TYPE-S FELL HEAD FIRST OFF THE HEAD END OF THE COUCH. ACCORDING TO THE THERAPIST, THE PT DID NOT HAVE ANY VISIBLE INJURIES. PT GOT UP OFF THE FLOOR BY THEMSELVES, BUT THEY SENT PT TO HAVE A CT.