MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2026
Type of Reportable Event	Death
Event or Problem Description
Hamilton medial ag received the following complaint description (summary): it was reported that immediately after the start of ventilation of the hamilton-c1, alarms including "disconnection on patient side," "maximum leak compensation," "vt low," and "low minute volume" occurred repeatedly.At approximately 12:00, ventilation was switched to manual ventilation; however, the patient subsequently died.The investigation to verify the allegation is still in progress.
Additional Manufacturer Narrative
Hamilton medical ags reference: (b)(4); investigation is ongoing.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• 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: 25886065
• Report Number: 3001421318-2026-00448
• Device Sequence Number: 9967304
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)190221(240)161001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 161001
• Device Catalogue Number: 161001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2019
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown