MAXVENTURI R211P03-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817770020448), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2021Off-Label Use; Off-Label Use

  FACILITY STATED THE FOLLOWING: PATIENT'S MAXIVENT ALARMED (EXP HEATER WIRE) NO VISIBLE CAUSE. COULD VISUALLY SEE THAT WATER HAD POOLED IN THE TUBE, DRAINED 150ML BACK INTO HUMIDICATION CIRCUIT. PATIENT STATED IT FELT HOT AND LESS POWERFUL. NEAR MISS AS PATIENT COULD HAVE BEEN EXPOSED TO LARGE VOLUMES OF WATER THROUGH NASAL PASSAGE - TUBING HAD BEEN CHECKED AND DRAINED THROUGHOUT THE SHIFT AND REGULAR INSPECTED FOR FAULTS. THIS INCIDENT HAS OCCURED ON MORE THAN ONE OCCASION WITH MULTIPLE DEVICES WITH VARYING VOLUMES OF FLUID.

  Patient problems: Discomfort

  MAUDE report 11422511 ↗