HAMILTON-BC8022 260161Recalls & reported problems
Hamilton Medical AG · HAMILTON-BC8022, breathing circuit set, dual limb, heated, with water chamber · 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 07630002801560), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
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.
MalfunctionJun 5, 2025Leak/Splash; Leak/Splash
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "ACTIVE HUMIDIFICATION IS INSTALLED AND VENTILATION IS STARTED FOR A DEEPLY SEDATED AND VENTILATED PATIENT WITH NORADRENALINE COMING OUT OF SURGERY. SUBSEQUENTLY, WATER LEAKS FROM THE HUMIDIFIER CHAMBER, CAUSING A CONTINUOUS ALARM ON THE VENTILATOR; THE ENTIRE VENTILATOR HAD TO BE REPLACED, AND THE PATIENT HAD TO BE BAGGED DURING THIS TIME IN AN UNSTABLE CIRCULATION SITUATION". THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. PENDING FOR BREATHING CIRCUIT SET TO BE RETURNED TO HAMILTON MEDICAL FOR FURTHER INVESTIGATION. THE INCIDENT DIRECTLY OR INDIRECTLY LED, MIGHT HAVE LED, OR MIGHT LEAD TO DEATH OR A SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON. THEREFORE, THIS EVENT IS ASSESSED AS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154340 ↗
Other Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer devices
- VOCSN V*Home, EnglishVentec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer4 deaths318 reports
- F&P Evaqua 2 RT380Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer305 reports
- F&P Evaqua 2 RT265Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer114 reports
- F&P Evaqua 2 RT266Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
- AirLife™ AH165Airlife · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall1 report
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- AirLife™ AH165Airlife · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1 recall0 reports
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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