N/A 7900-0Recalls & reported problems
Salter Labs · Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607411700057), received between Jun 5, 2024 and Jun 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
- Partial Blockage1
Patient problems
- Hypoxia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2024Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow
HUMIDIFIER BOTTLE PREVENTING CORRECT FLOW OF OXYGEN (AS SET BY FLOWMETER) TO PATIENT RESULTING IN HYPOXIA. MULTIPLE HUMIDIFIER BOTTLES WITH SAME LOT NUMBER RESULTED IN SAME (REPRODUCIBLE IN SAME LOT). USE OF DIFFERENT LOT NUMBER RESOLVED ISSUE.
Patient problems: Hypoxia
MAUDE report 19470495 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Optiflow Junior 2 OJR414Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)56 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.