REUSABLE FLEXIBLE TUBING
Received Mar 19, 2019 · Event occurred Mar 11, 2019
Report 2518422-2019-00623 · MDR key 8433523
Device
Generic name
Accessory To Continuous Ventilator (respirator)
Model number
622038Catalog number
622038
Lot number
120418
Product problems
- Collapse
- Collapse
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR CIRCUIT TUBING "CRUSHED IN ON ITSELF." AT THIS TIME, IT IS NOT KNOWN IF INTERVENTION WAS REQUIRED. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
IT WAS INITIALLY REPORTED, THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR CIRCUIT TUBING "CRUSHED IN ON ITSELF." THE TUBING WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO DEFORMITIES OR MATERIAL ABNORMALITIES WERE OBSERVED. THE MANUFACTURER CONCLUDES THE TUBING IS WITHIN DESIGN SPECIFICATIONS.