MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical reference number: b4 this report also contains the investigation outcome.Hamilton medical ag received the logfiles of the device for analysis.Upon review of the logfiles, the issue reported by the user could be confirmed.The device alarmed with technical fault - tf 5509 and tf 9907 on the day of the event, b6.It is important to emphasize that no patient was involved at the time the alarm occurred.Please see below extract from the logfiles.B6 17:20:02 tf : 9907 tech fault 9907 b6 17:20:01 tf : 2803 15295 tech fault 2803 b6 17:20:01 tf : 2801 500 tech fault 2801 b6 17:20:01 tf : 2804 1 tech fault 2804 b6 17:20:01 tf : 2402 6 tech fault 2402 b6 17:20:01 tf : 2414 tech fault 2414 b6 17:20:01 audio paused off special 517 b6 17:20:01 audio paused off special 517 b6 17:20:01 ambient irreversible setting 233 b6 17:20:01 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.Further on, the tf 9907 indicates faulty communication between integrated panel processor (ipp) (panel) and ventilation unit processor vup (vu).Therefore, to address the issue, the inspiratory valve assembly was replaced.Following the replacement, full calibration and functional testing were performed, confirming that the device operates in accordance with its intended performance specifications.Hamilton medical considers this case closed.
Event or Problem Description
Hamilton medical ag received the following event description: "tf: 9907 & 5509 alarm, and the unit cannot use." 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 Contact: roxana elena huiet ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 24964644
• Report Number: 3001421318-2026-00229
• Device Sequence Number: 10496047
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)210506(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 159001
• Device Catalogue Number: 159001
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 05/06/2021
• 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