MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "inspiratory valve malfunction.Failed during startup.Tf5509 and tf9907.Occurs every time vent is powered on" no patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).This report also contains the investigation outcome.According to the complaint form, the even occurred during a test.During start-up of the ventilator, when it's power on, the device alarms with technical fault (tf) 5509 and tf 9907.It is important to emphasize that no patient was involved at the time the alarm occurred.According to the service manual for hamilton-g5, tf5509 indicates that the error servo signal remains active for 5 seconds, indicating that the servo (inspiratory) valve is not functioning correctly.Further on, the tf 9907 indicates faulty communication between ipp (panel) and vup (vu).The log file has not been provided.This case is being assessed based on the available information.Therefore, to address the issue, the servo module was replaced.Following replacement of the component, the issue was resolved.Hamilton medical considers this case closed.

• 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: 24964394
• Report Number: 3001421318-2026-00228
• Device Sequence Number: 18749019
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)210315(240)159002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 159002
• Device Catalogue Number: 159002
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 03/15/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown