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	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.No.: (b)(4).Investigation outcome.Based on the analysis of the logfiles provided, all important actions such as operator settings, actions and alarms, system behavior were properly recorded.The log files confirm that technical fault tf 5507 occurred on multiple occasions and was last recorded on february 19, 2026, while the ventilator was in standby mode.No patient involvement was reported.Prior to this incident, the first occurrence of alarm tf5507 was recorded in the log files on (b)(6), during ventilation of a patient.Ventilation continued and no health or consequences to the patient were reported.During the onsite visit, the service technician performed troubleshooting activities and identified a defective sensor board as root cause of incident.The sensor board was replaced and following replacement all functional tests and ventilator checks passed.It was therefore confirmed that the corrective action resolved the issue and the ventilator operating as intended.
Event or Problem Description
It was reported to hamilton medical ag that on 19.02.2026 they have seen a random error tf5507.After this, during test use with test lung, the fault tf5507 appeared with increased frequency.No patient involvement 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: roxana huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24543068
• Report Number: 3001421318-2026-00105
• Device Sequence Number: 5662495
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)191001(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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
• Device Model Number: 159001
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 10/01/2019
• 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