MalfunctionBTC
PORTEX
Received Jul 29, 2020 · Event occurred Jun 16, 2020
Report 10337946 · MDR key 10337946
Device
Generic name
Bag, Reservoir
Manufacturer
Smiths Medical International LtdModel number
C45091711-NLCatalog number
C45091711-NL
Lot number
3772292
Product problems
- Material Rupture
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
WHILE CHECKING POSITIVE PRESSURE IN THE ANESTHESIA BREATHING CIRCUIT PRIOR TO AN ANESTHETIC, THE BREATHING BAG SPONTANEOUSLY RUPTURED.