MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Codes	Imprecision (1307); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
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 coded appeared.I checked all connections, everything was okay the mask had minimal leak at 7%.Then multiple error codes appeared really fast and the unit switched to cmv mode on its own and would not switch back to niv st" no health consequences or impact.However, because the respiratory technician was unable to change the mode, they removed this unit from service.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: hamilton medical ag has received a customer complaint regarding a hamilton-c1 ventilator showing loss of peep codes, minimal leak at 7% and multiple error codes appeared really fast and the unit switched to cmv mode on its own and would not switch back to niv st".This record contains information on patient involvement.Although medical intervention was required (ventilation replacement), neither harm to patient nor user or third party was reported.The ventilator alarmed and automatic mode transition were most likely caused by a temporary loss or degradation of flow measurement rather than a confirmed hardware defect.The issue could not be reproduced during service testing, supporting the likelihood of an intermittent or setup-related problem such as improper connection or tubing obstruction.No hardware fault was identified.Therefore, this case is considered as closed.

• 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: 24330223
• Report Number: 3001421318-2026-00063
• Device Sequence Number: 9754710
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)230119(240)1610010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/27/2026

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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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