MalfunctionCAF
VIOS LC AEROSOL DELIV SYST
Received May 18, 2026 · Event occurred Apr 11, 2026
Report MW5188316 · MDR key 25201757
Device
Generic name
Nebulizer (direct Patient Interface)
Manufacturer
Pari Respiratory Equipment, Inc.Patient
82 YR · Male
- Insufficient Information
Narrative
Description of Event or Problem
INDICATION: OTHER MALAISE; CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED; CENTRILOBULAR EMPHYSEMA. THE PATIENT'S DAUGHTER REPORTS THE VIOS DELIVERY SYSTEM HAD NO MOUTHPIECE. THE BACK UP BAG, HAS A MOUTH PIECE, BUT IT IS TOO SMALL FOR NEBULIZER CUP AND IT SAYS IT IS ONLY MEANT TO FOR TEMPORARY USE. UNKNOWN IF AN ADVERSE EVENT OCCURRED, UNKNOWN IF THE DEVICE IS ON HAND FOR RETURN, UNKNOWN IF THE PATIENT MISSED A DOSE. NO ADDITIONAL INFORMATION PROVIDED.