MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: it was reported that a patient was connected to the hamilton-c3 device (under sedation, analgesia, and intubation).No patient harm was reported, and the patient was subsequently transferred to another device.The patient had been connected to a hamilton-c3 device, which could not be improved despite repeated troubleshooting.This resulted in a rapid respiratory rate, poor oxygenation maintenance, and a worsening of the patient¿s condition.After replacing the ventilator, the tidal volume returned to normal, and ecg monitoring indicated improved oxygenation and respiratory parameters.Root cause: air leakage during ventilator use led to low tidal volume.This was traced to a damaged expiratory valve membrane.The incident is attributed to maintenance issues and is not related to the inherent quality of the ventilator.Corrective action: the defective expiratory valve membrane was replaced.The device subsequently passed all service software checks and was returned to use.Case is closed.
Event or Problem Description
Hamilton medical ag received the following event description (summary): it was reported that a patient was connected to the hamilton-c3 (under sedation, analgesia, and intubation).No patient harm was reported, and the patient was subsequently transferred to another device.The patient had been connected to a hamilton-c3 device, which could not be improved despite repeated troubleshooting.This resulted in a rapid respiratory rate, poor oxygenation maintenance, and a worsening of the patient¿s condition.After replacing the ventilator, the tidal volume returned to normal, and ecg monitoring indicated improved oxygenation and respiratory parameters.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24895361
• Report Number: 3001421318-2026-00208
• Device Sequence Number: 10476246
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)171017(240)160005
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201306
• 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
• Report Date (Section B): 04/16/2026

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: 160005
• Device Catalogue Number: 160005
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2017
• 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