MaxVenturi R211P03-036Recalls & reported problems
Maxtec, LLC · DISS, Pole Clamp, Medline Private Label · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817770020912), received between May 21, 2021 and May 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
EVENT TITLE: - -CONFIDENTIAL- -. DESCRIBE THE EVENT OR PROBLEM,: PATIENT WAS ON A HIGH-FLOW CANNULA AT 100%; CANNULA STOPPED DELIVERING OXYGEN; PATIENT WAS PLACED ON BIPAP AND THERE WAS NO KNOWN HARM TO THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: HIGH FLOW OXYGEN. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864089 ↗
Other Analyzer, Gas, Oxygen, Gaseous-Phase devices
- NOxBOXi NOXBOX-INoxbox Ltd · Analyzer, Gas, Oxygen, Gaseous-Phase6 recalls5 deaths121 reports
- O2-Sensor MLF-16IT Dr. Gambert GmbH · Analyzer, Gas, Oxygen, Gaseous-Phase61 reports
- BIRD SENTRY2 30623-001Carefusion Corporation · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- MAXO2 ME R230P01Maxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- Vital Signs™ 8004463AirLife Finland Oy · ANALYZER, GAS, OXYGEN, GASEOUS-PHASE1 report
- Vital Signs™ 73319-HELAirLife Finland Oy · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- Oxygen Sensor MAX-125MMaxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- MAXVENTURI R211P03-027Maxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.