MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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 the hamilton-g5 ventilator: ¿when i plugged it in the board where the power cord plugs into started smoking¿.No patient was involved at the time of the event.No intervention was required, and no health effects or consequences to any patient were reported.
Additional Manufacturer Narrative
Hamilton medical reference number: (b)(4).Investigation outcome: the following event was reported related hamilton-g5 ventilator: "when i plugged it in the board where the power cord plugs into started smoking".There was no patient involvement.No parts were returned to hamilton medical ag, neither device logs or pictures were provided with this complaint.Hamilton medical ag has requested further information.However, no further information was received.The most probable root cause was a defective power cord.After replacement of the power cord the device was returned to service and operates according to its intended performance.This case is considered as closed.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: roxana huiet ; via crusch 8; bonaduz
• MDR Report Key: 24637684
• Report Number: 3001421318-2026-00147
• Device Sequence Number: 10008817
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)171108(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): 04/08/2026

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
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 11/08/2017
• 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