MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	1610010
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference nr: (b)(4).Investigation outcome: the device alarmed for various technical faults and switched into safety ventilation.The reported issue can be evidenced from attached device logs.The issue could not be reproduced.Local service engineer upgraded the device to the last software version (3.1.1) the device passed all calibration and tests in service software.The reported issue could not be reconstructed.This case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: "as per the end user, ventilator has shut down itself with continuous audible alarms.After the end user turned on the device, alarms stopped.There were technical faults.Tf 346040, tf 346054, tf 346041, tf385002." it was marked in the complaint that no patient was involved.The case has not been reviewed yet by hamilton medical ag.Therefore the failure description could not be confirmed yet.

• Brand Name: HAMILTON-C1
• Common Device Name: HAMILTON-C1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: christof müller ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24257594
• Report Number: 3001421318-2026-00052
• Device Sequence Number: 8327218
• Product Code: CBK
• UDI-Device Identifier: 07630002813426
• UDI-Public: (01)07630002813426(11)220927(240)1610010
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 1610010
• Device Catalogue Number: 1610010
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 09/27/2022
• 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