MalfunctionMNK
MOUTHPIECE
Received Jul 7, 2026 · Event occurred Jun 16, 2026
Report 9610595-2026-54873 · MDR key 25742623
Device
Product problems
- Residue After Decontamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE MOUTHPIECE HAD A WHITE POWDER-LIKE SUBSTANCE SOMETIMES ADHERES TO THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.