MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-C2

Model Number	160002
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 admitted to the hospital due to acute myocardial infarction and heart failure.During the process of assisted breathing with a ventilator, the motor malfunctioned, which may have caused a power failure in the system due to prolonged operation of the ventilator, resulting in the ventilator being unable to function properly and endangering the patient's life.Other invasive ventilators were immediately adjusted for the patient's use.After examination, it was found that the fan blades were stuck and the coil was burned, causing the compressor to overheat and protect.The patient returned to the factory to replace the cooling fan and eliminate the fault." (2) no clinical signs, symptoms or conditions.No health consequences or impact.
Additional Manufacturer Narrative
The following was reported: "during the use of the machine, a fan defect alarm occurred.After reporting to the biomed department, the biomed department informed the third-party maintenance personnel to replace the fan, and the defect was solved.The machine is currently in normal use.As the defect occurred during use of the ventilator and an alternative one was immediately used, no injury was caused to the patient." the provided log files do not cover the date of the event.

• 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: 21123495
• Report Number: 3001421318-2025-00102
• Device Sequence Number: 18001290
• Product Code: CBK
• UDI-Device Identifier: 07630002800730
• UDI-Public: (01)07630002800730(11)190130(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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• 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
• Patient Sex: Unknown