INTELECT XT 4CH COMBO
Received Nov 7, 2011 · Event occurred Aug 10, 2011
Report 9616086-2011-00128 · MDR key 2329943
Product problems
- Insufficient Device Problem Information
Patient
73 YR
- Burn, Thermal
Narrative
Description of Event or Problem
CLINICIAN NOTIFIED DJO THAT PT UNDERGOING THERAPY WITH DJO PRODUCED INTELECT XT 4CH COMBO CLINICAL ELECTROTHERAPY BURN PT WHICH LEFT A SMALL RED MARK ON THE BACK OF THE PT. THERAPY WAS DISCONTINUED. UNKNOWN IF FURTHER INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
DEVICE WAS EVALUATED BY DJO TECHNICAL SERVICE. CHANNEL 1 LEAD WIRE EXHIBITED IMPEDANCE GREATER THAN 2 OHM MAXIMUM. CHANNEL 2 LEAD WIRE WAS OPEN. THIS CONDITION MAY HAVE LEAD TO THE BURN THE PT REPORTED. INITIAL REPORT DATED (11/03/2011) WAS SUBMITTED UNDER DUPLICATE REPORT NUMBER. CORRECT NUMBER IS 9616086-2011-00128 AS ENTERED ON THIS FORM 3500A. INCORRECT REPORT NUMBER WAS 9616086-2011-00128.