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	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Event or Problem Description
It was reported to hamilton medical ag that: ¿vent began auto-triggering on patient and there was substantial patient volume loss.Patient bagged while flow sensor, filters, and disposable exhalation valve changed.When the attempt was made to pre-use check the vent after the flow sensor change, we were unable to perform a leak test or a flow sensor calibration test.The vent would not cycle through the tests as if it were frozen.Switched out ventilator, patient issue resolved and now stable on new ventilator.¿ a patient was involved and medical intervention (manual ventilation) was required.However, no adverse health consequences or injuries to the patient were reported.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: roxana elena huiet ; via crusch 8; bonaduz
• MDR Report Key: 24727931
• Report Number: 3001421318-2026-00170
• Device Sequence Number: 18690090
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)220922(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,Followup
• Report Date (Section B): 03/30/2026

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: 159002
• Device Catalogue Number: 159002
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• 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