MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
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.All important actions such as operator settings, actions and alarms, etc.Are documented in the logfiles.Based on the logfile analysis, the customer¿s reported issue has been confirmed.The device generated an alarm tf 5505, 5502.On (b)(6) 2025, 15:31:07 tf : 5505 tech fault 5505, on (b)(6) 2025, 15:31:06 ets 25 % setting 319, on (b)(6) 2025, 15:31:04 audio paused off special 517, on (b)(6) 2025, 15:31:04 tf : 5502 tech fault 5502, on (b)(6) 2025, 15:31:03 audio paused off special 517, on (b)(6) 2025, 15:31:02 audio paused off special 517, on (b)(6) 2025, 15:31:02 tf : 5505 tech fault 5505, on (b)(6) 2025,15:31:02 screen lock on special 518, on (b)(6) 2025, 15:31:01 nebulizer off special 501, on (b)(6) 2025, 15:31:01 nebulizer on special 500, on (b)(6) 2025, 15:31:00 o2 enrichment special 512.To address the issue a replacement inspiratory valve was sent to the end customer.Following the replacement of the inspiratory valve, the device worked as intended.Hamilton medical considers this case as closed.
Event or Problem Description
Hamilton medical ag received the following event description: the device alarmed with tf 5505, 5502.The patient was switched to alternative ventilator 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: 23412387
• Report Number: 3001421318-2025-00882
• Device Sequence Number: 8956606
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)231122(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/29/2025

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: 10/21/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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