HYPERINFLATION SYSTEM, .5L
Received Jul 30, 2024 · Event occurred Jul 2, 2024
Report 1417592-2024-00771 · MDR key 19860430
Device
Generic name
Hyperinflation System, .5l
Manufacturer
Medline Industries LpCatalog number
DYNJAAHY005
Lot number
24EBB017
Product problems
- Inflation Problem
- Inflation Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BAG WOULD NOT INFLATE WHEN ATTEMPTING TO BAG. WHEN UTILIZING A FLOW RATE OF 10LPM THE BAG WOULD NOT INFLATE TO PROVIDE CPAP. IT WAS REPORTED, "THERE WAS ALSO AN ISSUE WHEN IT CAME TO ADJUSTING THE PEEP".
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BAG WOULD NOT INFLATE WHEN ATTEMPTING TO BAG. WHEN UTILIZING A FLOW RATE OF 10LPM THE BAG WOULD NOT INFLATE TO PROVIDE CPAP. IT WAS REPORTED, "THERE WAS ALSO AN ISSUE WHEN IT CAME TO ADJUSTING THE PEEP". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.