MalfunctionIPF
INTELECT MOBILE 2CH STIM
Received May 27, 2009
Report 1022819-2009-00148 · MDR key 1455865
Device
Product problems
- Energy Output To Patient Tissue Incorrect
- Self-Activation or Keying
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS FOR EXPORT ONLY. AWAITING RETURN AND EVALUATION OF THE DEVICE. THE FINAL INVESTIGATION FINDINGS WILL BE REPORTED TO THE FDA MDR.
Description of Event or Problem
THE CUSTOMER WAS APPLYING STIM THERAPY USING THE TENS CURRENT WHEN THE CURRENT INCREASED FROM 20 TO 90 AUTOMATICALLY.