CHATTANOOGA
Received Oct 1, 2025 · Event occurred Sep 4, 2025
Report 9616086-2025-00062 · MDR key 23190145
Device
Product problems
- Mechanical Problem
- Unintended System Motion
- Unintended Movement
- Mechanical Problem
- Unintended System Motion
- Unintended Movement
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PATIENT'S 5TH SESSION, LUMBAR PROTOCOL, WITH A PREDEFINED PROGRAM (MAX TRACTION: 33 KG / MIN: 12 KG / EXPECTED DURATION: 32 MIN). AS USUAL, THE PATIENT WAS PROPERLY POSITIONED, WITH SECURING STRAPS, WEDGES AT THE LEVEL OF THE ARMPITS, AND HAD THE EMERGENCY STOP CONTROL. AFTER ABOUT 12 MINUTES, SCREAMS WHERE HEARD AND INTERVENED IMMEDIATELY. THE PATIENT WAS FOUND COMPLETELY PULLED DOWN AT THE END OF THE TABLE. THE THORACIC BELT HAD SLIPPED TO THE LEVEL OF HER FACE AND EYES, HER ARMS WERE IN THE AIR, THE ARMPIT WEDGES HAVING FAILED TO PREVENT HER BEING PULLED, THE TRACTION CABLE WAS RETRACTED ALMOST TO ITS MAXIMUM, WITH A VERY HIGH TENSION. THE RELEASE BUTTON OF THE CORD DID NOT WORK IMMEDIATELY. IT WAS ONLY AFTER SEVERAL PRESSES THAT IT FINALLY RELEASED THE PULL, ALLOWING THE PATIENT TO BE FREED. FORTUNATELY, IT WAS MORE FEAR THAN HARM. THE PATIENT WAS NOT INJURED BUT WAS STRONGLY SHAKEN BY THE EXPERIENCE. THE PATIENT EXPLAINED TO ME THAT EVERYTHING WAS GOING NORMALLY, THEN THE TRACTION SUDDENLY ACCELERATED WITHOUT HER HAVING THE TIME TO REACH THE EMERGENCY STOP BUTTON.
Additional Manufacturer Narrative
IT WAS REPORTED THAT DURING THE PATIENT'S 5TH SESSION, LUMBAR PROTOCOL, WITH A PREDEFINED PROGRAM (MAX TRACTION: 33 KG / MIN: 12 KG / EXPECTED DURATION: 32 MIN). AS USUAL, THE PATIENT WAS PROPERLY POSITIONED, WITH SECURING STRAPS, WEDGES AT THE LEVEL OF THE ARMPITS, AND HAD THE EMERGENCY STOP CONTROL. AFTER ABOUT 12 MINUTES, SCREAMS WHERE HEARD AND INTERVENED IMMEDIATELY. THE PATIENT WAS FOUND COMPLETELY PULLED DOWN AT THE END OF THE TABLE. THE THORACIC BELT HAD SLIPPED TO THE LEVEL OF HER FACE AND EYES, HER ARMS WERE IN THE AIR, THE ARMPIT WEDGES HAVING FAILED TO PREVENT HER BEING PULLED, THE TRACTION CABLE WAS RETRACTED ALMOST TO ITS MAXIMUM, WITH A VERY HIGH TENSION. THE RELEASE BUTTON OF THE CORD DID NOT WORK IMMEDIATELY. IT WAS ONLY AFTER SEVERAL PRESSES THAT IT FINALLY RELEASED THE PULL, ALLOWING THE PATIENT TO BE FREED. FORTUNATELY, IT WAS MORE FEAR THAN HARM. THE PATIENT WAS NOT INJURED BUT WAS STRONGLY SHAKEN BY THE EXPERIENCE. THE PATIENT EXPLAINED TO ME THAT EVERYTHING WAS GOING NORMALLY, THEN THE TRACTION SUDDENLY ACCELERATED WITHOUT HER HAVING THE TIME TO REACH THE EMERGENCY STOP BUTTON. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSED COULD NOT BE ESTABLISHED. IF MORE INFORMATION COMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.