MalfunctionIPF
CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPL
Received Mar 23, 2020 · Event occurred Mar 13, 2020
Report 9616086-2020-00012 · MDR key 9864812
Product problems
- Intermittent Energy Output
- Intermittent Energy Output
Patient
Not reported
- Electric Shock
- Electric Shock
Narrative
Additional Manufacturer Narrative
INVESTIGATION REVEALED A DEFECTIVE ULTRASOUND PROBE CABLE AND RUBBER BODY SEPARATING. PARTS WERE REPLACED AND APPLICATOR WAS CALIBRATED. CLEANED UP UNIT, CONTACTS, AND RE-SEATED BOARDS. FULL FUNCTIONAL TEST WAS RAN.
Additional Manufacturer Narrative
NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE INTENSITY GOES UP ON ITS OWN AND CANNOT BE CONTROLLED; IT GETS VERY HIGH AND SHOCKED A PATIENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.