CHATTANOOGA TX TRACTION UNIT PKG
Received Apr 29, 2019 · Event occurred Apr 3, 2019
Report 9616086-2019-00020 · MDR key 8562142
Product problems
- Unintended Movement
- Patient Device Interaction Problem
- Unintended Movement
- Patient Device Interaction Problem
Patient
NA · Unknown
- Pressure Sore/Ulcer
- No Known Impact Or Consequence To Patient
- Pressure Sore/Ulcer
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT INDICATE THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE AS SUCH, A FOLLOW-UP REPORT WILL BE COMPLETED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT "IT IS HAVING AN INTERMITTENT ISSUE... WHEN THE UNIT HAS BEEN SITTING IDLE WITH THE ROPE OUT AND THEY GO TO REMOVE ALL OF THE SLACK ONCE ATTACHED TO THE PATIENT, THEY PRESS THE ROPE RELEASE AND IT VIOLENTLY SNAPS BACK WITH FORCE AND A LOUD NOISE. THEN THE ROPE RELEASE WILL OPERATE NORMALLY AGAIN IN AND OUT UNTIL IT HAS BEEN SITTING IDLE AGAIN FOR SOME TIME." THERE WAS NO REPORTED PATIENT HARM.
Additional Manufacturer Narrative
PRODUCT NOT RETURNED FOR INSPECTION AND COMPLAINT COULD NOT BE CONFIRMED IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.