MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).This report also contains the investigation outcome.It was reported that a hamilton-g5 ventilator generated technical fault tf 5507.Patient involvement was reported.However, no medical intervention was required, and no adverse health effects or consequences to the patient were reported.The technical fault occurred after attempts to calibrate the device, including calibration of the pressure at zero and full scale, as well as calibration of the differential pressure (dp) mixer valve.Log files were not provided for further technical analysis.This limitation restricted the ability to perform a detailed retrospective investigation and to confirm the exact sequence of events leading to the technical fault.Therefore, the assessment of the case was conducted based on the available information.Based on the investigation, the most probable root cause of the reported event was identified as a defect in the sensor board.As a corrective action, a replacement sensor board was provided to the customer, which resolved the issue.The case is considered as closed.
Event or Problem Description
Hamilton medical ag received the following event description: "tf 5507 happened after calibration attempted to calibrate the pressure at 0 and full scale.Tried calibrating the dp mixer valve" it was reported no health consequences or impact to any patient.No intervention necessary.

• 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: 25215985
• Report Number: 3001421318-2026-00310
• Device Sequence Number: 21276707
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)190830(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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2019
• 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