SALTER LABS
Received Feb 18, 2022 · Event occurred Feb 17, 2022
Report 1314417-2022-00006 · MDR key 13563602
Device
Product problems
- Unexpected Therapeutic Results
Patient
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
REBREATHING CO2 CAN CAUSE PERMISSIVE HYPERCARBIA. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.
Description of Event or Problem
RESUSCITATION BAG IS RETAINING CO2, CAUSED PATIENT TO RE-BREATHE EXHALED CO2. NO OTHER NEGATIVE IMPACT.
Additional Manufacturer Narrative
REBREATHING CO2 CAN CAUSE PERMISSIVE HYPERCARBIA. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT OF BACKWARDS LEAK WAS CONFIRMED DURING THE INVESTIGATION. FURTHER TESTING SHOWS THAT ALL RESUSCITATION BAGS, WITH AND WITHOUT MANOMETER, MEET THE ISO STANDARDS. UPDATES TO THE INSTRUCTIONS FOR USE WILL BE ROUTED THROUGH THE CHANGE CONTROL PROCESS, WHICH IS OUTLINED IN SUNMED'S QUALITY MANAGEMENT SYSTEM.
Description of Event or Problem
RESUSCITATION BAG IS RETAINING CO2, CAUSED PATIENT TO RE-BREATHE EXHALED CO2. NO OTHER NEGATIVE IMPACT.