MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Codes	Failure to Calibrate (2440); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag comes to the following conclusion: investigation ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: (1) detailed complaint and failure description: "the report from hospital say: the patient was given a hamilton c2 ventilator on (b)(6) 2024 due to heart failure.Self check of the ventilator before use failed.The nurse immediately stopped using it and replaced it with another ventilator to treat the patient." (2) insufficient information.
Additional Manufacturer Narrative
The following was reported: "during preoperational check the self-test failed." no patient involvement reported.No logfiles provided.Team china visited the hospital to check the device.It was recalibrated and "the internal accessories were reinstalled." issue solved.

• Brand Name: HAMILTON-C2
• Common Device Name: HAMILTON-C2
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, switzerland 7402 ; CH 7402
• Manufacturer Contact: daniel elice ; via crusch 8; bonaduz, switzerland 7402 ; SZ 7402
• MDR Report Key: 21078503
• Report Number: 3001421318-2025-00016
• Device Sequence Number: 8497937
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(11)150629(240)160002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121225
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2025

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: 160002
• Device Catalogue Number: 160002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2015
• 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