EXOGEN ULTRASOUND HEALING SYSTEM
Received Mar 8, 1999 · Event occurred Feb 3, 1999
Report MW1015854 · MDR key 213347
Device
Generic name
External Ultrasound Healing System
Manufacturer
Exogen, Inc.Model number
THM MODEL 2000Catalog number
NA
Lot number
NA
Product problems
- Component(s), worn
- Design/structure problem
- Electrical /Electronic Property Problem
- Repair
- Replace
- Inadequate Service
- Other (for use when an appropriate device code cannot be identified)
Patient
48 YR
- Therapy/non-surgical treatment/delayed/prolonged
Narrative
Description of Event or Problem
DR STATES SYSTEM WORKS VERY WELL FOR PTS WHEN IT WORKS, BUT AFTER 50-60 USES THE HEAD WEARS OUT OR GETS GEL TRAPPED INSIDE, LEADING TO SHORT CIRCUITING. IN HIS CASE, HE HAS RETURNED THE DEVICE FOR REPAIR OR REPLACEMENT. THE CO CHECKS IT OUT AND RETURNS IT TO HIM SAYING THAT IT IS FUNCTIONING. HE FINDS THAT IT ISN'T AND LOSES MORE TIME BETWEEN TREATMENTS. RPTR FEELS THAT THE CO SHOULD PROVIDE BETTER SERVICE TO THEIR PTS, BY SENDING NEW UNITS IN EXCHANGE FOR FAULTY ONES AND PERHAPS IMPLEMENT AN AUTOMATIC REPLACEMENT IF THE HEAD AFTER 50-60 TREATMENTS. THESE STEPS, THE RPTR FEELS, WOULD PREVENT PTS FROM LOSING TREATMENT EFFECTS WAITING FOR REPAIR OR REPLACEMENT. IF THESE STEPS ARE NOT TAKEN, THE RPTR FEELS THAT THE DEVICE SHOULD BE RECALLED FOR REDESIGN.