MalfunctionITH
TRITON
Received Mar 18, 2014 · Event occurred Feb 20, 2014
Report 9616086-2014-00007 · MDR key 3847675
Product problems
- Device Operates Differently Than Expected
Patient
55 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT RECEIVED FROM CLINICIAN THAT ALLEGES "THE UNIT KEEPS PULLING AFTER TREATMENT". QUESTIONNAIRE RECEIVED FROM CLINICIAN STATING NO INJURY, PATIENT FELT UNIT CONTINUED PULLING AND PUSHED BUTTON TO STOP. NO INJURY, THEREFORE NO MEDICAL TREATMENT AT TIME OF INCIDENT OR AFTER. PRODUCT NOT RETURNED TO MANUFACTURER FOR REVIEW. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT, INJURY OR DEATH.