MalfunctionITH
CHATTANOOGA
Received Dec 3, 2014 · Event occurred Nov 20, 2014
Report 9616086-2014-00019 · MDR key 4317189
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT RECEIVED FROM CUSTOMER THAT ALLEGES "WHEN THE MACHINE IS STARTED THERE IS TRACTION FORCE OF 2 - 3 LBS WITHOUT EVEN SETTING ANY PARAMETERS AND IF THEY PUT MORE THAN 40 LBS THEN IT KEEPS ON PULLING AND DOES NOT STOP". QUESTIONAIRE NOT RECEIVED FROM CLINICIAN AND/OR PT. DEVICE NOT RETURNED TO MFR FOR EVAL. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.