MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).
Event or Problem Description
Hamilton medical ag received the following event description: "loss of peep, high breath rate.Moved patient to another ventilator.Ventilator serviced by onsite biomed on 10-02-2025.Account manager completed functional testing 11/17 with no issues." 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.So far, no relation to the device has been established.
Additional Manufacturer Narrative
Investigation outcome: it was reported that a ventilator experienced loss of peep accompanied by high respiratory (breath) rate.As a result, the patient was "moved to another ventilator".However, there was no report of harm to patient, user or third party, nor a treatment in delay.The device was serviced onsite by the biomed on october 2, 2025.Pre-op checks performed on november 12, 2025, with no issues found.A circuit disconnection was suggested as a possible cause, but this is unconfirmed.Information about the breathing circuit and accessories used for patient ventilation was requested but not provided.However, the customer stated this event occurred on two separate patients during niv, and that there was no indication of leaks for the masks used.The software was updated to 3.1.1, and all service software tests were performed without failures.The issue was not duplicated and the cause could not be established.This case is considered as close.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz
• MDR Report Key: 23654165
• Report Number: 3001421318-2025-00931
• Device Sequence Number: 21346013
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)240416(240)1610010
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 1610010
• Device Catalogue Number: 1610010
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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