PORTEX
Received Nov 24, 2021 · Event occurred Oct 27, 2021
Report 3012307300-2021-11822 · MDR key 12870071
Device
Product problems
- Defective Device
- Defective Device
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ADDITIONAL INFORMATION H.6: METHOD, RESULT, AND CONCLUSION CODES WERE ADDED. ADDITIONAL INFORMATION H.10: DEVICE EVALUATION: ONE TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION IN RELATION TO THE REPORTED EVENT. VISUAL INSPECTION OF THE DEVICE WAS ABLE TO CONFIRM THE REPORTED EVENT. UNDER VISUAL INSPECTION IT WAS NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. ROOT CAUSE WAS UNABLE TO BE DETERMINED DUE TO THE NATURE OF THE REPORTED EVENT. DHR REVIEW WAS UNABLE TO BE PERFORMED AS NO LOT INFORMATION WAS AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT WHILE IN USE, THE CUSTOMER PULLED THE PILOT BALLOON GENTLY, BUT IT GOT DETACHED FROM THE INFLATION LINE EASILY. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.