MalfunctionISD
LOKOMAT-SYSTEM
Received Apr 27, 2005 · Event occurred Apr 15, 2005
Report 3003781275-2005-00001 · MDR key 598264
Device
Product problems
- Break
Patient
43 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
FOLLOWING 20 MINUTES OF TRAINING A MOTOR COMPLETE, CHRONIC SPINAL CORD INJURED PATIENT AT 2.8KM/HR AND AT 55KG OF BODY-WEIGHT SUPPORT, THE UNLOADING ROPE BROKE. THE LOCATION OF THE BREAK WAS APPROXIMATELY 16 INCHES ABOVE THE HORIZONTAL CORSS BAR LOCATED ABOVE THE SUBJECT. THE LOCATION OF THE BREAK ON THE ROPE APPEARED TO BE AT ABOUT THE POSITION THE ROPE WOULD BE EXPECTED TO BE ON THE OVER-HEAD PULLEY. INSPECTION OF THE ROPE AT THE LOCATION OF THE BREAK REVEALED A BRITTLE TEXTURE, AS THE ROPE HAD BEEN SUBJECTED TO HIGH TEMPERTURES AS MIGHT OCCUR UNDER FRICTION CONDITIONS. NO INJURIES RESULTED.
Remedial action
- Modification/Adjustment
- Recall