PRIMUSRS
Received Apr 6, 2018 · Event occurred Mar 1, 2018
Report 1119903-2018-00001 · MDR key 7405254
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE UNIT COMMUNICATION LOGS MATCH THE SCENARIO AND TIMELINE DESCRIBED BY THE CUSTOMER AND INDICATE THAT USER ERROR CAUSED THE INCIDENT. THE THERAPIST SET VERY LOW RESISTANCE FORCES THAT WERE UNDER 1 LB. HOWEVER, THE THERAPIST WAS PROBABLY EXPECTING A MUCH HIGHER RESISTANCE WHEN USING THE SYSTEM. HE FELL BECAUSE THERE WAS NO RESISTANCE ON THE CABLE DUE TO HIS DATA ENTRY ERROR. THE EQUIPMENT IS CAPABLE TO PROVIDE UP TO 140 LBS. RESISTANCE WHILE TOOL 191 IS UTILIZED.
Description of Event or Problem
PHYSICAL/OCCUPATIONAL THERAPIST THAT OPERATED THE DEVICE WAS DEMONSTRATING A PULL EXERCISE. HE INTENDED TO WALK BACKWARDS WHILE PULLING TOOL 191 CABLE. HE PULLED ON THE CABLE AND LOST HIS BALANCE DUE TO NO RESISTANCE. HE FELL AND IS AWAITING AUTHORIZATION FOR PHYSICAL THERAPY FOR LOWER BACK INJURY.