MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: "i found alarm tf 5509,9907 when turn on unit." patient was involved.No intervention necessarily, no health or consequences to the patient was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4) investigation outcome.It was reported to hamilton medical ag: "i found alarm tf 5509,9907 when turn on unit." patient was involved.No intervention necessarily, no health or consequences to the patient was reported.The root cause was determined to be a defective inspiratory valve assembly.The component was replaced by a technician, and following calibration, the ventilator passed functional checks and operated as intended.

• 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: 24517438
• Report Number: 3001421318-2026-00102
• Device Sequence Number: 8522276
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)201110(240)159001
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 03/05/2026

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: 02/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 11/10/2020
• 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