MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Codes	Defective Alarm (1014); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "during patient use, the ventilator generated a continuous non-silenceable alarm and was reported as failed.The patient was manually ventilated while a replacement ventilator was deployed.The faulty unit continued to emit a persistent alarm tone even after removal from the patient.Error codes: 'technical event: 246005", followed by tf 485001, tf 431001, tf 446029; 'ventilation cancelled'" no health consequences or impact.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Hamilton medical ag ref nr: (b)(4).
Additional Manufacturer Narrative
Investigation outcome: this complaint is duplicate of our reference nr: (b)(4), fda mfr report nr: (b)(4).Therefore, this case is considered as closed.It was reported that during "dta" workshop initial performance testing in service software, the ventilator passed all tests up to page 2104 (pneumatics 2 / blower flow).At that point, the test sequence was interrupted when technical fault 444005 (shut down failed) appeared, followed by safety ventilation 346049 (watch dog failed snd_sound).These technical errors were not evidenced from review of device logs; however, tf 444004 (voltage out of tolerance) was indicated; suggesting power instability.It was additionally reported that during patient use (prior to sending in the device for service), the device generated a continuous alarm that could not be silenced and was reported as failed.The patient was manually ventilated while a replacement device was deployed.The faulty device continued to emit persistent audible alarming even after removal from the patient.Technical errors: 246005 (alarm monitor defect), 485001 (ambient failure detected), 431001 (blower fault), 446029 (ambient failure detected).There was no of harm to patient, user or third party, nor a treatment in delay.No interruption of ventilation or medical intervention was reported.Clarification requested on reported event.

• Brand Name: HAMILTON-T1
• Common Device Name: HAMILTON-T1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 24130954
• Report Number: 3001421318-2026-00031
• Device Sequence Number: 5371074
• Product Code: CBK
• UDI-Device Identifier: 07630002801850
• UDI-Public: (01)07630002801850(11)200603(240)161006
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 161006
• Device Catalogue Number: 161006
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown