MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: after startup, the ventilation starts with an audible high-priority sound and a visual alarm with the tf9907.In standby mode, no pre-operational check is available.In calibration mode, no flow is delivered during the inspiratory valve calibration.No patient was involved as per provided information.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation ongoing.

• 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
• Manufacturer Contact: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 23702440
• Report Number: 3001421318-2025-00946
• Device Sequence Number: 10628680
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)171023(240)159001
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 159001
• Device Catalogue Number: 159001
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2017
• 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