TYPE-S SYSTEM
Received Jun 16, 2006 · Event occurred Jun 1, 2006
Report 1932738-2006-00004 · MDR key 727127
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Fall
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
FACILITY DOES NOT WANT TO DISCUSS THE ISSUE OR PROVIDE INFORMATION REGARDING THE PATIENT WITH CIVCO. BASED ON INITIAL COMMENTS FROM THE FACILITY, THE PATIENT REPOSITIONED THEMSELVES WITHOUT ASSISTANCE. THE USER MANUAL CONTAINS CAUTIONS AND WARNINGS FOR THE OPERATOR NOT TO ALLOW THE PATIENT TO REPOSITION THEMSELVES WITHOUT ASSISTANCE. ALSO, SAFETY STRAPS WERE SUPPLIED TO THE FACILITY, BUT THEY DO NOT USE THEM.
Description of Event or Problem
CUSTOMER NOTIFIED CIVCO THAT ALTHOUGH PHYSICIANS WERE NOT PERFORMING ANY TREATMENT AT THE TIME, THE PATIENT SHIFTED THEMSELVES, APPLYING EXTRA WEIGHT TO THE SUPERIOR SIDE OF THE TABLE AND FELL TO THE GROUND. PATIENT WAS DIAGNOSED TO HAVE A FRACTURED BACK. SAFTEY STRAPS HAD BEEN SENT TO THE FACILITY IN 2005, BUT THEY DO NOT USE THEM.