MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (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 generated tf 5510 and tf 5511 on the day of the event.It is important to emphasize that no harm to the patient was reported.Please see below extract from the logfiles: (b)(6) 2025, 02:19:54 low tidal volume alarms 4005; (b)(6) 2025, 02:19:43 low tidal volume alarms 4005; (b)(6) 2025, 02:19:36 p-trigger 2.0 -cmh2o setting 303; (b)(6) 2025, 02:19:36 tf: 5511 tech fault 5511; (b)(6) 2025, 02:19:36 tf: 5510 tech fault 5510; (b)(6) 2025, 02:19:36 calibration autozero failed calibration 614; (b)(6) 2025, 02:19:34 calibration autozero failed calibration 614; (b)(6) 2025, 02:19:34 flow sensor calibration needed alarms 3005; (b)(6) 2025, 02:19:24 low tidal volume alarms 4005; (b)(6) 2025, 02:19:07 low tidal volume alarms 4005; (b)(6) 2025, 02:18:49 low tidal volume alarms 4005.The root cause was identified as a defective sensor board, which was subsequently replaced.Following the replacement, the device functioned as intended.Hamilton medical ag considers this case closed.
Event or Problem Description
Hamilton medical ag received the following event description: the device generated tf5510 and tf5511 the patient had to be taken off the ventilator and ventilated with ambu.No harm to the patient 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 (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: 24276048
• Report Number: 3001421318-2026-00055
• Device Sequence Number: 8318346
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)200721(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
• Report Date (Section B): 02/06/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2020
• 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