inforMED
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)

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.