HAMILTON-T1 161005Recalls & reported problems
Hamilton Medical AG · Class 2
All models of HAMILTON-T1 (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630002800754), received between Sep 13, 2024 and Oct 24, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).
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/Air Leak2
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: DEVICE SHUT DOWN DURING VENTILATION.
Patient problems: Insufficient Information
MAUDE report 20522035 ↗MalfunctionOct 22, 2024Gas/Air Leak; No Apparent Adverse Event; Gas/Air Leak; No Apparent Adverse Event
THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: LOUD NOISES FROM VENTILATOR. LEAKING AT RESPIRATORY VALVE. THE DEVICE DOES NOT PASS TIGHTNESS TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504327 ↗MalfunctionOct 22, 2024Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information
THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: DELIVERED OXYGEN IS 70-75% AT A 90% SETTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504313 ↗MalfunctionOct 9, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: OPTIONS DISAPPEARED / OPTIONS NOT FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406353 ↗MalfunctionSep 13, 2024Gas/Air Leak; Gas/Air Leak
THE EVENT DESCRIPTION ACCORDING TO THE CUSTOMER IS AS FOLLOWS: CUSTOMER COMPLAINED OF REPLACING EXPIRATORY VALVE ASSM AND CHECKVALVE MORE THAN NORMAL EVERY 3 MONTHS TYPICAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210873 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 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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