SYSTEM 3
Received Aug 3, 2001 · Event occurred Jun 28, 2001
Report 2431314-2001-00001 · MDR key 345682
Device
Generic name
Multi-joint Test & Rehab Device
Manufacturer
Biodex Medical Systems, Inc.Model number
SYSTEM 3Catalog number
830-200
Lot number
*
Product problems
- Use of Device Problem
Patient
UNKNOWN
- Dural Tear
- Amputation
- Crushing Injury
- Other (for use when an appropriate patient code cannot be identified)
- Hospitalization required
Narrative
Description of Event or Problem
THE CONCERNED PERSON HAS BEEN ATTENDED IN THE CONTINUOUS PASSIVE MOTION OF THE BIODEX PRO 3. THE PERSON WAS VERY DISQUIETINGLY AND TINKERED WITH THE DEVICE. THE CONCERNED PERSON'S LEFT TRIGGER FINGER INTERVENED BETWEEN THE ADAPTER AND THE MOTION MECHANICAL STOP OF THE DYNAMOMETER HEAD OF THE BIODEX. THE CONCERNED PERSON'S FINGER HAS BEEN SWATTED AND CONCERNED PERSON HAD TO BE ATTENDED IN THE AMBULANCE OF THE HOSPITAL. DIAGNOSIS: RIP WOUND ON THE LEFT FINGER WITH PARTIAL AMPUTATION, LEFT TRIGGER FINGER, EFIPHYSOLOYSE OF THE TERMINAL LINK.
Remedial action
- Other