TRITON DTS PKG US STD
Received Jan 14, 2019 · Event occurred Dec 21, 2018
Report 9616086-2019-00004 · MDR key 8245034
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TRACTION MACHINE "WILL PULL OR RELEASE ROPE WITHOUT ANY WARNING". THE EVENT REPORTEDLY OCCURRED WHILE TESTING THE MACHINE; THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE AS SUCH, A FOLLOW-UP REPORT WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. WE COULD NOT REPLICATE THE ROPE PULLING TOO HARD OR FEEDING OUT ON ITS OWN; THE SAFETY RISK COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL FUNCTIONAL TESTING BUT WOULD NOT RETURN ALL THE WAY TO ZERO POUNDS; IT WENT DOWN TO 4 POUNDS. THIS WOULD NOT HAVE CONTRIBUTED TO THE INCIDENT OR HAVE BEEN A SAFETY RISK AS IT STILL RETURNED TO THE RANGE WHERE THE ROPE COULD RELEASE. THE MOTOR CONTROL CIRCUIT BOARD WAS REPLACED AND THE DEVICE WAS CALIBRATED. THE SPRING WAS REPLACED BECAUSE THE ROPE WOULD NOT RETRACT ALL THE WAY INTO THE DEVICE. THIS WOULD NOT HAVE CONTRIBUTED TO THE EVENT.