MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: "end user of device says after 15 minutes of use, the device stopped delivering breaths.Low minute volume and oxygen supply fail." the patient had to be temporarily bagged.However, no health consequences or impact occurred.The case has not been reviewed yet by hamilton medical ag.Therefore, the failure description could not be confirmed yet and so far, no relation to the device has been established.
Additional Manufacturer Narrative
Hamilton medical ag ref nr: comp- (b)(4).
Additional Manufacturer Narrative
Investigation outcome: it was reported that after 15 minutes of use, the device stopped delivering breaths and the patient was bagged as a result.No health consequences or impact.The provided complaint form states that "low minute volume" and 'oxygen supply failed" alarms were noted and that the "display showed two red dashes under peak pressure" per review of logs, on the reported event date of june 23, 2025; there was ventilation on simv+ with multiple standbys before resuming simv+ ventilation.No technical events (te) or technical faults (tf) were noted; however, multiple low-high priority alarms were logged on this day: 'low oxygen', 'oxygen supply failed', 'loss of external power', 'pressure limit has changed', 'maximum leak compensation', 'inspiratory volume limitation', 'loss of peep', 'pressure limitation', 'vt low', 'high frequency', 'disconnection on patient side', 'high minute volume', and 'low minute volume'.Hamilton medical ag has requested further information.However, no further information was received.This case is considered as closed.If further information is received that changes this assessment, a follow-up report will be submitted.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz
• MDR Report Key: 22456045
• Report Number: 3001421318-2025-00681
• Device Sequence Number: 12840864
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)211129(240)161009
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 161009
• Device Catalogue Number: 161009
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown