PRIMUS
Received Aug 17, 2017 · Event occurred Jul 11, 2017
Report 1119903-2017-00003 · MDR key 6802106
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 ROOT CAUSE OF THE INCIDENT IS USER ERROR: THE OPERATOR LOST BALANCE AND STUMBLED.
Description of Event or Problem
WHILE ATTEMPTING TO CALIBRATE THE PRIMUS, THE PHYSICAL THERAPIST MISSED THE SLOT IN THE CALIBRATION BAR WHERE THE CALIBRATION WEIGHT SHOULD BE HUNG AND LOST BALANCE. SHE HIT HER FACE ON THE CALIBRATION BAR OR WEIGHT, BREAKING HER NOSE. SHE REQUIRED SURGERY AT THE ER AND MISSED A FEW DAYS OF WORK. AFTER RETURNING TO WORK, THE THERAPIST CALLED BTE CUSTOMER SUPPORT WITH QUESTIONS REGARDING THE EQUIPMENT, SHE THEN DESCRIBED THE INCIDENT. SHE STATED THAT SHE WAS DOING WELL AND WAS SUFFERING NO ILL EFFECTS.