MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).This report also contains the investigation outcome.Logfiles were provided and reviewed.The reported self-test failed alarm could not be confirmed from the available logfile data.However, technical faults tf 5509 and tf 9907 were recorded in the device logs.According to the investigation, tf 5509 indicates that the inspiratory valve servo control was operating outside specification.The condition was identified during inspection and confirmed through service troubleshooting.Replacement of the servo module resolved the issue, and all subsequent calibrations, functional checks, and ventilation tests were completed successfully.The device was restored to normal operation and returned to service.No patient involvement, serious injury, or adverse health consequences were reported.Based on the confirmed technical faults recorded in the logfile and the need for corrective service intervention, the event is considered reportable.The investigation is complete and the case is closed from the manufacturer's perspective.
Event or Problem Description
Hamilton medical ag received the following event description: "during inspection, we found that a self-test failed alarm was displayed on the machine.We suspected an issue with the servo module.To confirm the fault, we cross-checked by installing a new servo module, and the machine operated normally.Therefore, the faulty servo module was replaced with a new one.All tests and calibrations were completed successfully after the replacement.The machine was handed over to the customer in good working condition." no patient involvement was reported.No harm, serious injury or adverse health consequences to any patient were reported.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: roxana elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25664229
• Report Number: 3001421318-2026-00398
• Device Sequence Number: 18743626
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)210518(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K193228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 159001
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown