MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following event description: during ventilation, the device was auto-cycling and alarmed with disconnection on ventilator side.No harm to the patient was reported.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 25298989
• Report Number: 3001421318-2026-00331
• Device Sequence Number: 15794715
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)170411(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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 05/19/2026
• Initial Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 04/11/2017
• 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