MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: during the ventilation of a patient, the device alarmed with disconnection on ventilator side.No harm to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).The report contains also the investigation outcome.Hamilton medical ag received the logfiles of the device for analysis.Upon review of the logfiles, the issue reported by the customer could be confirmed.The device alarmed with the disconnection on ventilator side on the day of the event.The event occurred during ventilation, however, no harm to the patient was reported.2025-10-24 09:20:52 disconnection on ventilator side alarms (b)(6).2025-10-24 09:20:29 high tidal volume alarms (b)(6).2025-10-24 09:20:11 audio paused on special (b)(6).2025-10-24 09:20:09 audio paused off special (b)(6).2025-10-24 09:20:00 audio paused on special (b)(6).2025-10-24 09:19:02 disconnection on ventilator side alarms (b)(6).Following the event, during troubleshooting test mode 13, ppat (patient pressure) and paw (airway pressure) were not running in tandem.The root cause was determined to be a defective inspiratory valve.After the valve was replaced, the device passed all functional tests and operated as intended.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): 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: 23725434
• Report Number: 3001421318-2025-00950
• Device Sequence Number: 10670511
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)201021(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/05/2025

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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