MalfunctionITH
TRITON DTS PKG US STD
Received Jan 30, 2019 · Event occurred Oct 1, 2018
Report 9616086-2019-00005 · MDR key 8288448
Product problems
- Unintended System Motion
- Unintended System Motion
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION THEREOF.
Description of Event or Problem
IT WAS REPORTED THAT THE TRACTION DEVICE POWERED OFF AND TURNED ON AGAIN DURING TREATMENT. IT THEN SUDDENLY PULLED ON THE PATIENT'S NECK. THERE WAS REPORTEDLY NO PATIENT INJURY.