Bio-Med Devices, Inc. 2003FLEURecalls & reported problems
Bio-Med Devices, Inc. · Air / Oxygen Blender low flow with EU flowmeter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00813841020355), received between Oct 21, 2025 and Oct 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas Output Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gas Output Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Gas Output Problem; Gas Output Problem
AIR/OXYGEN BLENDER NOT FUNCTIONING, CAUSING DELAY IN GETTING PATIENT SET UP AT HIGHER OXYGEN LEVEL. NO INJURY TO PATIENT.
Patient problems: Insufficient Information
MAUDE report 23352651 ↗
Other Accessory To Continuous Ventilator (Respirator) devices
- Bio-Med Devices, Inc. 2003GEBio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)3 recalls10 reports
- Bio-Med Devices, Inc. 2003FFBBio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
- Bio-Med Devices, Inc. 2003FFHBio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
- Bio-Med Devices, Inc. 2003FFE5Bio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
- Bio-Med Devices, Inc. 2003IBio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
- Bio-Med Devices, Inc. 2001Bio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
- Bio-Med Devices, Inc. 2003KCBio-Med Devices, Inc. · Accessory To Continuous Ventilator (Respirator)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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