MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C3

Model Number	160005
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4).Hamilton medical ags conclusion: investigation ongoing.
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): hamilton medical ag received a report indicating that the battery was not charging while connected to the mains power supply, which led to intermittent shutdowns of the unit.The event occurred without patient involvement.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Follow up information: the customer reported the event date as 07 november 2025.Log entries from this date are not available due to the device¿s 1000-event buffer limitation, which resulted in overwriting of earlier data.Review of later log files from 01 january 2026 shows repeated transitions between ac power and battery operation, including entries such as ac battery, battery ac, and ¿loss of external power¿, indicating intermittent or unstable ac power supply.Additional data retrieved via service software show occurrences of tf444001 (batteries totally discharged) and tf446029 (ambient failure detected).A log sequence dated (b)(6) 2025 indicates that the ventilator was operating in ventilation software mode at the time these events were recorded.Due to the absence of log data covering the originally reported event date, activation of ventilation and patient involvement cannot be confirmed based on the available logs.At the same time, active therapy cannot be ruled out.A follow up with the partner is still pending.

• Brand Name: HAMILTON-C3
• Common Device Name: HAMILTON-C3
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz
• MDR Report Key: 24198758
• Report Number: 3001421318-2026-00039
• Device Sequence Number: 5469749
• Product Code: CBK
• UDI-Device Identifier: 07630002801881
• UDI-Public: (01)07630002801881(11)220725(240)160005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 06/18/2026

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
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 06/18/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/17/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• 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