VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA
Received Nov 10, 2021 · Event occurred Sep 12, 2021
Report 8030673-2021-00210 · MDR key 12788935
Device
Generic name
Hyperinflation Bag System
Manufacturer
Vyaire MedicalCatalog number
5102RVW
Lot number
UNKNOWN
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- Pneumothorax
- Pneumothorax
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO PHOTOS AVAILABLE. THEREFORE, NO ROOT CAUSE HAS BEEN DETERMINED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ FLOW INFLATING TAIL-END VALVE TRANSPORT CIRCUIT, FLOW-INFLATING TRA EXPERIENCED VALVE CLOSES TOO EASILY WHICH CAUSED HIGH PRESSURES TO ENTER LUNGS AND RESULTED IN PNEUMOTHORAX. AS AN INTERVENTION, INTUBATED INFANT BEING GIVEN MANUAL BREATHS.