MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C1

Model Number	161001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: during transport, the ventilator initially functioned normally but subsequently shut down, displaying a white screen and alarm (tf 432001, 446029, 485001).The device did not deliver volume or ventilate until it was powered off and restarted.No harm to the patient was reported additionally, it was mentioned that the user reported the event to the local authorities.The reference number provided is ref#: (b)(4).
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation 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: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25078972
• Report Number: 3001421318-2026-00254
• Device Sequence Number: 10425034
• Product Code: CBK
• UDI-Device Identifier: 07630002800747
• UDI-Public: (01)07630002800747(11)201105(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
• Report Date (Section B): 05/05/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 11/05/2020
• 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