MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 alarmed with tf 5509 and other several technical faults on the day of the event.It is important to emphasize that no patient was involved at the time the alarm occurred.Please see below extract from the logfiles.On (b)(6) 2025, 08:53:11, tf: 9907 , tech fault 9907, (b)(6) 2025, 08:53:10, body wt 71.00 kg setting 325, (b)(6) 2025, 08:53:10, patient height 175 cm setting 326, (b)(6) 2025, 08:53:10, tf : 2803 -25227 tech fault 2803, (b)(6) 2025, 08:53:10, tf : 2801 500 tech fault 2801, (b)(6) 2025, 08:53:10, tf : 2804 1 tech fault 2804, (b)(6) 2025, 08:53:10, tf : 2402 7 tech fault 2402, (b)(6) 2025, 08:53:10, tf : 2414 tech fault 2414, (b)(6) 2025, 08:53:10, low minute volume alarms 5006, (b)(6) 2025, 08:53:10, tf : 2736 354 , tech fault 2736, (b)(6) 2025, 08:53:10, tf : 2736 354 , tech fault 2736, (b)(6) 2025, 08:53:10, tf : 2736 354 , tech fault 2736, (b)(6) 2025, 08:53:10, tf : 2736 354 , tech fault 2736, (b)(6) 2025, 08:53:10 , tf : 2736 354 , tech fault 2736, (b)(6) 2025, 08:53:10 , audio paused off special 517, (b)(6) 2025, 08:53:10 , audio paused off special 517, (b)(6) 2025, 08:53:10 , standby off special 507, (b)(6) 2025, 08:53:10, ambient irreversible setting 233, (b)(6) 2025, 08:53:10 , tf : 5509 , tech fault 5509.According to the service manual for hamilton-g5, tf5509 indicates that the error servo signal remains active for 5 seconds, indicating that the servo (inspiratory) valve is not functioning correctly.Therefore, to address the issue, the inspiratory valve was replaced.Following replacement of the component, the issue was resolved.Hamilton medical considers this case closed.
Event or Problem Description
Hamilton medical ag received the following event description: the device generated tf5509 , tf9907 and tf2414 - no patient involvement.

• 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: 24176579
• Report Number: 3001421318-2026-00034
• Device Sequence Number: 10178447
• Product Code: BSK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)200622(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): 01/26/2026

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: 01/20/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2020
• 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