MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to hamilton medical ag the technical event error 8912 - pump runs and has pressure but never shuts off and does not reach target pressure of 25, pump is leaking.At the time of the event, the patient was connected to the ventilator.No intervention was deemed necessary, and no injury or adverse health consequences were reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation is ongoing.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: roxana elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25406572
• Report Number: 3001421318-2026-00359
• Device Sequence Number: 10748805
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)160922(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2016
• 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