VYAIRE OY
Received Mar 28, 2024 · Event occurred Feb 1, 2024
Report 3010838917-2024-00201 · MDR key 19000960
Device
Product problems
- No Pressure
- No Pressure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SYSTEM COULD NOT PRESSURIZE.
Additional Manufacturer Narrative
THE SYSTEM IS NOT ABLE TO PRESSURIZE AND WOULD CAUSE A DELAY IN THE PATIENT'S TREATMENT OF THERAPY. CUSTOMER COMPLAINED ABOUT "NOT WORKING PROPERLY/BROKEN-WONT PASS MORNING CHECK OUT". DEFECTIVE CANISTER WAS DISPOSED, NO SAMPLE, NO PHOTOS PROVIDED. FAILURE MODE CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED. REVIEWED SHA - RMF-HL-0053 - CO2 ABSORPTION PRODUCTS AND COMPONENTS - MDD - REV07 - 12-DEC-2023. I CONCLUDED THAT CLOSEST RISK ID COULD BE: SHA-HL-0053-044; HAZARD CATEGORY: MANUFACTURING, PACKAGING OR SHIPPING PROBLEM.
Description of Event or Problem
SYSTEM COULD NOT PRESSURIZE.
Additional Manufacturer Narrative
THE SYSTEM IS NOT ABLE TO PRESSURIZE AND WOULD CAUSE A DELAY IN THE PATIENT'S TREATMENT OF THERAPY.