MalfunctionITH
TRACTION UNIT, POWERED, MOBILE
Received Mar 7, 1995 · Event occurred Jan 18, 1995
Report 20694 · MDR key 20694
Device
Product problems
- Increase in Pressure
Patient
45 YR
- Headache
- Pain
Narrative
Description of Event or Problem
PT PRESENTED FOR OUTPATIENT CERVICAL TRACTION TREATMENT. HAD USED SAME MACHINE SEVERAL TIMES BEFORE AS AN INPATIENT. PT WAS GIVEN CALL LIGHT AND KILL SWITCH FOR MACHINE. TREATMENT BEGAN AT 20 LBS, WAS GRADUALLY INCREASED TO 25 LBS. APPROX 5 MINS AFTER TRACTION INCREASE THE PT CALLED OUT AND STOPPED THE MACHINE. HE COMPLAINED THAT THE PULL HAD INCREASED AND PULLED THE HALTER AND HEAD REST OFF OF HIS HEAD AND NECK. HE DENIED ANY PAIN OR DIZZINESS IMMEDIATELY AND THE TREATMENT WAS DISCONTINUED. THE MACHINE WAS TAKEN OUT OF SVC AND CHECKED BY THE CLINICAL ENGINEERING DEPT.