MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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: the device alarmed with tf's 9907, 9421 during ventilation.The ventilator was replaced.No harm to the patient was reported.According to the log file analysis, a panel connection lost alarm was recorded prior to the technical faults (tf's) mentioned by the user.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Hamilton medical ag received the log files for analysis.Review of the log files showed that the device generated a ¿panel connection lost¿ alarm, followed by multiple technical faults (tf 2414, tf 9421, tf 9907, tf 2804, tf 2801, and tf 2803) and an ambient-related event.Please see an extract from the log files below: 2025-12-01 10:45:03 ambient irreversible setting 233.2025-12-01 10:45:03 tf: 2803 29102 tech fault 2803.2025-12-01 10:45:03 tf: 2801 492 tech fault 2801.2025-12-01 10:45:03 tf: 2804 1 tech fault 2804.2025-12-01 10:45:03 tf: 9907 tech fault 9907.2025-12-01 10:45:03 tf: 9421 tech fault 9421.2025-12-01 10:45:03 tf: 2414 tech fault 2414.2025-12-01 10:45:03 low minute volume alarms 5006.2025-12-01 10:45:02 audio paused off special 517.2025-12-01 10:45:02 tf: 2453 tech fault 2453.2025-12-01 10:45:02 panel connection lost alarms 4010.To date, despite several reminders, the manufacturer has not received any additional information or confirmation as to whether the issue was resolved.No further feedback was received.No parts were replaced, the corrective action remains unknown, and the exact root cause could not be confirmed.This case is considered 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: 24017078
• Report Number: 3001421318-2026-00010
• Device Sequence Number: 10584018
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)151209(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): 04/21/2026

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: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2015
• 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