MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: the customer reported that tf9950 had been displayed.No health consequences or impact.Based on the log file analysis, no occurrence of tf9950 was recorded.However, the following technical faults were identified in the device logs: tf9907, tf2414, and tf5509.
Additional Manufacturer Narrative
Follow-up 1 : investigation outcome.It was reported that technical fault tf9950 had been displayed.Hamilton medical ag received the device log files for analysis.Upon review of the log files, no occurrence of tf9950 was recorded.However, the following technical faults were identified in the device logs: tf9907, tf2414, and tf5509, along with additional technical faults.The log data indicate that ventilation was stopped and the device switched to ambient state following the occurrence of tf5509 and tf9907.Additionally, a ¿power fail¿ and a corresponding ¿restart after power fail¿ were recorded on the date of the reported incident.No patient harm was reported, and no medical intervention was reported.Technical fault 5509 indicates that the error servo signal remains active for 5 seconds, indicating that the servo (inspiratory) valve is not functioning correctly.Technical fault 9907 indicates a faulty communication between ipp (panel) and vup (ventilation unit).The root cause was determined to be a defective inspiratory valve, which was replaced.Following the replacement, the device worked as intended.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 24206948
• Report Number: 3001421318-2026-00042
• Device Sequence Number: 9654120
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)190417(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/04/2026

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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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