MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that the device alarmed with exhalation obstruction alarms during ventilation of a patient.No health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
It was reported that the device generated repeated ¿exhalation obstructed¿ alarms.This behavior could not be confirmed due to the absence of device log files.Replacement of the breathing circuit and expiratory valve cover did not resolve the issue, suggesting the root cause may not have been external disposable components.Based on the available information, the device exhibited intermittent ¿exhalation obstructed¿ alarms occurring approximately every three to four months, which could not be replicated during prior troubleshooting.The exhalation valve had previously been replaced; however, the issue persisted, indicating that the initial intervention did not resolve the root cause.Following consultation with technical support, the check valve assembly (msp161192) was identified as the most probable contributing component and was replaced.After repair, the device underwent annual preventive maintenance and was tested under simulated neonatal conditions for approximately 16 hours, during which no recurrence of the alarm was observed except when intentionally triggered.Given the intermittent nature of the issue and the long interval between occurrences (approximately 1500 operating hours), the effectiveness of the corrective action cannot be fully confirmed.However, the absence of alarm recurrence during extended functional testing suggests that the check valve assembly was the most probable root cause.The device was returned to use following successful completion of maintenance and testing.Hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 24544560
• Report Number: 3001421318-2026-00116
• Device Sequence Number: 5662554
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)190513(240)161001
• 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): 04/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: 161001
• Device Catalogue Number: 161001
• Was Device Available for Evaluation?: No
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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