MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-T1

Model Number	161006
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference nr.(b)(4).
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 patient was manually ventilated while a replacement ventilator was deployed.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.
Additional Manufacturer Narrative
Investigation outcome: it was reported that during patient ventilation, the device triggered a non-silenceable alarm and "was reported as failed".The team manually ventilated the patient while a replacement ventilator was deployed.The device alarming continued even after it was removed from the patient.Recorded technical errors included 246005 (alarm monitor defect), 446029 (ambient failure detected), 431001 (blower fault), 485001 (ambient failure detected).Additional information from the partner also stated ''ventilation cancelled' was displayed by the device during ventilation.There was no report of harm to patient, user or third party, nor a treatment in delay.Additional information was received: the device failed during patient use with continuous audio alarm as reported by customer.The device was sent in for service at the workshop, and the local service engineer performed service software testing up to page: blower flow (page no.2104) (pneumatics 2) when errors; tf: 444005 (shutdownfailed) and safety ventilation: 346049 (watchdogfailedsnd_sound) appeared but no alarming.All 6 led lights (next to the panel buttons) were lit and staying on.The device was powered off for a day, but all the leds were lit up immediately upon power on the day after.Additional updates from device service: -a rubber foot was found missing, right side cover and the rear covers filter cover¿s screw insert has damage.-the power cord needs to be replaced with h05 spec.The control board was replaced to resolve the issue.It was additionally noted the right and rear covers were replaced and the sw was upgraded to 3.1.1.The device pass all service software tests and related testing, and was returned to the customer.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 müller ; via crusch 8; bonaduz
• MDR Report Key: 23789425
• Report Number: 3001421318-2025-00969
• Device Sequence Number: 14845437
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown