MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161009
Medical Device Problem Codes	Failure to Charge (1085); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Event or Problem Description
The following was reported to hamilton medical ag: "during transport, device malfunctioned sending a critical battery disconnect error and stopped ventilating, they attempted to trouble shoot by plugging the device into wall plug, but that did not resolve the issue." no health consequences or impact.The case has not been reviewed yet; therefore, the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Investigation outcome: it was reported that during patient transfer the device alarmed for 'battery communication error' and stopped ventilation, consequently, patient was ventilated manually.In an attempt to restart the ventilator, the device was connected to ac mains, however, this did not fix the problem.In contrast from attached device logs, it can be evidenced that the device did alarm for 'battery communication error', however, the ventilation continued until it was switched to standby by user.The ventilation was started again with in few seconds and continued until nearly 13 minutes and finally stopped by user again.Investigation carried out by local service engineer could not duplicate the reported fault and identify any part as defective component.Battery connector board and batteries were replaced preventively.Device s passed all tests and returned to user.This case is considered as closed.

• 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: 22129709
• Report Number: 3001421318-2025-00637
• Device Sequence Number: 7390422
• Product Code: CBK
• UDI-Device Identifier: 07630002806091
• UDI-Public: (01)07630002806091(11)200803(240)161009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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
• Was Device Available for Evaluation?: No
• 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: 08/03/2020
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown