inforMED
MalfunctionISD

LOKOMAT-SYSTEM

Received Apr 27, 2005 · Event occurred Apr 15, 2005

Report 3003781275-2005-00001 · MDR key 598264

Device

Generic name

Powered Exercise Equipment

Manufacturer

Hocoma Ag

Model number

4.0

Catalog number

NA

Lot number

NA

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