MalfunctionCAF
VIOS LC AEROSOL DELIV SYST
Received Apr 16, 2026
Report MW5186928 · MDR key 24896353
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
INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED. PT REPORTED THE THREE- PART APPARATUS THAT IS PLACED IN THE MOUTH WHILE BREATHING IN, NEEDS REPLACEMENT. PT STATED IT ARRIVED WITH DIRT ON ONE PART, AND DAILY USAGE HAS TAKEN A TOLL ON IT, PT REPORTED DESPITE IT BEING SPONGED WITH SOAPY WATER AFTER EACH USE. UNKNOWN IF MD IS AWARE. UNKNOWN IF PT MISSED DOSES. NO ADVERSE REACTION REPORTED. UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.