HAMILTON-H900 950004Recalls & reported problems
Hamilton Medical AG · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630002801546), received between Feb 11, 2025 and Feb 11, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jan 5, 2021Completed
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Z-1385-2022 · Root cause: Employee error · FDA record ↗
Most reported problems
Device problems
- Contamination1
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.
DeathFeb 11, 2025Contamination; Contamination
INFANT WAS DIAGNOSED WITH A BACTERIAL INFECTION PSEUDOMONAS AERUGINOSA. IT WAS BELIEVED THAT THE ORIGIN WAS FROM THE HAMILTON H-900 DUE TO THE RAIN OUT. THE H900 WAS LATER DEEMED NOT TO BE THE SOURCE OF THE BACTERIA AND WAS NOT LIABLE. NO CULTURES ON PRODUCT, TESTING WAS COMPLETED (CONTEXT OF TESTING IS BIOBURDEN TESTING).
Patient problems: Insufficient Information
MAUDE report 21359268 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- 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.