MalfunctionCAF
VIOS LC AEROSOL DELIV SYST
Received Apr 6, 2026
Report MW5186402 · MDR key 24794221
Device
Generic name
Nebulizer (direct Patient Interface)
Manufacturer
Pari Respiratory Equipment, Inc.Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PATIENT REPORTED THE MEDICATION CUP TO AIR NOZZLE BLOWS OUT, BUT WHEN SHE PUTS TOP PART ON IT DOESN'T COME THROUGH AND THE OHTUVAYRE IS FOAMING UP IN THE CUP. DATE OF MALFUNCTION UNKNOWN. UNKNOWN IF PATIENT MISSED A DOSE. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF DEFECTIVE DEVICE IS ON HAND FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. DIAGNOSIS FOR USE: CHRONIC OBSTRUCTIVE PULMONARY DISEASE.