MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hamilton medical ag received the following event description: it was reported by the user of the device that the "device went into standby mode without interaction from staff." it was further reported that a code blue was initiated for the patient and that the patient was transferred to the emergency room.Investigation is ongoing to verify the allegations made in this complaint (as standby modus is normally the result of 2 human interactions with the device).Additionally, the case was reported by the user to the competent authority (fda).The reference number provided is (b)(4).
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Currently, the event is under thorough investigation to verify the reported allegations.It is important to note that activating the standby mode on a hamilton ventilator requires a two-step human intervention process.Pressing the "standby" hardkey and secondly press "activate standby" within 30 seconds.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24725382
• Report Number: 3001421318-2026-00159
• Device Sequence Number: 15774675
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)240126(240)1610010
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 1610010
• Device Catalogue Number: 1610010
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 01/26/2024
• 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: Life Threatening
• Patient Sex: Unknown