MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: during ventilation, the device alarmed with air supply failed and could not be cleared.Patient was removed from the device and placed on another one - no health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Logfile review confirmed repeated medium priority alarm ¿alm_air_supply,¿ consistent with the reported ¿air supply fail¿ alarm condition.The event log did not show evidence of a persistent external air supply loss or hardware gas supply failure, and no associated high priority oxygen-and-air supply alarm was active during the reviewed sequence.The reported alarm appears to have been intermittent, as the user reported that ventilation delivery remained stable with no loss of volumes or patient desaturation prior to device exchange.The most probable root cause is improper opening of the air inlet mixer valve and/or insufficient air supply pressure and flow.Despite several attempts, no information about the correction was provided.Root cause could not be conclusively determined from the available data.This case is considered closed.

• 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 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402
• MDR Report Key: 23714581
• Report Number: 3001421318-2025-00949
• Device Sequence Number: 8845446
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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 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: 12/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2016
• 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