MalfunctionBTC
WESTMED
Received Aug 13, 2021 · Event occurred Jun 22, 2021
Report 2028807-2021-00001 · MDR key 12320547
Device
Generic name
Flat Breathing Bag
Model number
BB3000LFBProduct problems
- Burst Container or Vessel
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE GREEN BREATHING BAG FROM THE ANESTHESIA KIT BUSTED DURING A CASE. NO PATIENT HARM WAS REPORTED.