MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
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: it was reported that the device alarmed with disconnection on patient side messages.No heath consequence or impact.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Hamilton medical ag received the logfiles of the device for analysis.Logfile review confirms frequent disconnection alarms accompanied by related alarms such as loss of peep, low minute volume, and maximum leak compensation.Based on alarm patterns , the most probable cause is a malfunction within the pneumatic control system (servo module), affecting pressure/flow delivery and triggering disconnection conditions.The issue is consistent with a defective servo module leading to unstable flow/pressure delivery and false or true disconnection detection.A servo module was sent to customer to address the reported issue.The manufacturer has not received any further information, nor have received any further complaints about this device.It is assumed that the problem has been solved after replacing the servo module.Hamilton medical ag considers this case closed.

• 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: 24244574
• Report Number: 3001421318-2026-00047
• Device Sequence Number: 9657878
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)230323(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,Followup
• Report Date (Section B): 04/29/2026

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 Device Available for Evaluation?: No
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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