MalfunctionLPQ
SAFHS
Received Aug 17, 1995 · Event occurred Jul 24, 1995
Report MW5000012 · MDR key 28791
Device
Generic name
Fracture Healing System
Manufacturer
Exogen, Inc.Product problems
- Electrical /Electronic Property Problem
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
A DEVICE FAILURE WAS REPORTED ON 7/24/95. A REPLACEMENT UNIT WAS SENT TO THE PT ON THE SAME DAY. IT WAS REPORTED THAT WHEN THE POWER SWITCH WAS TURNED ON THE FUSE BLEW AS DID THE REPLACEMENT FUSE. THIS OCCURRED AFTER THIRTY-THREE (33) TREATMENTS. UPON RETURN OF THE UNIT IT WAS FOUND THAT THE BRIDGE RECTIFIER WAS INOPERATIVE. THIS PROBLEM HAS NOT OCCURRED SINCE 1/95.