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	09/15/2025
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: after startup, the device generated an audible high-priority sound and a visual alarm with the tf9907.In calibration mode, no flow is delivered during the inspiratory valve calibration.No patient involved.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Follow-up 1: investigation outcome.After startup, the device generated an audible high-priority sound and a visual alarm with the tf9907.In calibration mode, no flow is delivered during the inspiratory valve calibration.No patient involved as per provided information.Hamilton medical ag received the device logfiles for analysis.The log review showed that the technical fault 9907 was recorded on (b)(6) 2025, and not on the reported event date (september 15, 2025).On (b)(6) 2025 17:35:46 power-off on (b)(6) 2025 power 3.On (b)(6) 2025 17:34:50 tf: 2803 -24647 tech fault 2803.On (b)(6) 2025 17:34:50 tf: 2801 492 tech fault 2801.On (b)(6) 2025 17:34:50 tf: 2804 2 tech fault 2804.On (b)(6) 2025 17:34:50 tf: 9907 tech fault 9907.On (b)(6) 2025 17:34:49 tf: 2803 -24648 tech fault 2803.On (b)(6) 2025 17:34:49 tf: 2801 504 tech fault 2801.On (b)(6) 2025 17:34:49 tf: 2804 1 tech fault 2804.On (b)(6) 2025 17:34:49 tf: 2402 7 tech fault 2402.On (b)(6) 2025 17:34:49 tf: 2414 tech fault 2414.On (b)(6) 2025 17:34:49 audio paused off special 517.On (b)(6) 2025 17:34:49 audio paused off special 517.On (b)(6) 2025 17:34:49 ambient irreversible setting 233.On (b)(6) 2025 17:34:49 tf: 5509 tech fault 5509.The root cause was identified as a defective inspiratory valve.Following replacement of the component, the device operated 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: 23401941
• Report Number: 3001421318-2025-00875
• Device Sequence Number: 9946111
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)180213(240)159001
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: 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: 10/19/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2018
• 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