MalfunctionBTM
DBD-RESUSCITATOR,MAN.ADLT,TUBE,FILTER,PE
Received Feb 18, 2025 · Event occurred Jan 21, 2025
Report 1417592-2025-00083 · MDR key 21401627
Device
Generic name
Dbd-resuscitator,man.adlt,tube,filter,pe
Manufacturer
Medline Industries LpCatalog number
CPRM1126FP
Lot number
40023010094
Product problems
- Improper Flow or Infusion
- Improper Flow or Infusion
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BVM WAS CAUSING "OXYGEN FLOW MALFUNCTION". DUE TO THIS END-TIDAL HAD RISEN INTO THE 60S, WITH FRACTION OF INSPIRED CO2 IN THE LOW 20S. A NEW DEVICE WAS USED WHICH RESOLVED THE ISSUE.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.
Description of Event or Problem
BVM OR OXYGEN FLOW MALFUNCTION.