TRITON DTS PKG US STD
Received Apr 16, 2024 · Event occurred Feb 1, 2024
Report 9616086-2024-00025 · MDR key 19122354
Product problems
- Key or Button Unresponsive/not Working
- Key or Button Unresponsive/not Working
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "WARRATY REPAIR, ERROR 208 AND 309, THE MAX LOAD WAS SET TO 40# AND IT CONTINUED TO PULL TO 60#, THE ROPE RELEASE WOULD NOT RELEASE PATIENT AT END OF THE TRACTION TREATMENT EVEN AFTER HITTING EMERGENCY BUTTON, NO INJURY REPORTED."
Additional Manufacturer Narrative
IT WAS REPORTED THAT "WARRATY REPAIR, ERROR 208 AND 309, THE MAX LOAD WAS SET TO 40# AND IT CONTINUED TO PULL TO 60#, THE ROPE RELEASE WOULD NOT RELEASE PATIENT AT END OF THE TRACTION TREATMENT EVEN AFTER HITTING EMERGENCY BUTTON, NO INJURY REPORTED." THE DEVICE WAS RETURNED AND EVALUATED. THE UNIT NEEDED A NEW SOLENOID. SOLENOID REPLACED, TOUCHSCREEN BACK COVER REPLACED AND THE RIBBON CABLE THAT CONNECTS TO THE MAIN PCB BOARD. THE CLAMP FOOT WAS BENT, SO IT WAS ALSO REPLACED. SENT A NEW PATIENT SWITCH AS THE OTHER ONE WAS NO LONGER FUNCTIONING. THE CALIBRATION WAS SET EXTREMELY HIGH, THE UNIT WAS RECALIBRATED AND A BURN IN WAS PERFORMED FOR 8 HOURS. NO ISSUES OR DEFECTS WERE DISCOVERED DURING THIS PROCESS.