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	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: the ventilator hamilton-g5 is experiencing technical faults (tf) 5510 and 5511.No patient involvement was reported.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Hamilton medical ag ref.No.(b)(4).Follow-up1: investigation outcome.Logfiles were received for analysis.All relevant device actions, including settings adjustments, alarms, and operational events, are appropriately documented in the logfiles.The device logfiles confirm the reported issue, however, the recorded occurrence date is 27.01.2026, which differs from the customer reported event date of 04.02.2026.No patient involved.According to the logfile analysis the device alarmed with technical faults (tf) 5510 and 5511, furthermore, the calibration autozero failed.2026-01-27 23:04:06 audio paused on special 516.2026-01-27 23:03:49 p-trigger 2.0 -cmh2o setting 303.2026-01-27 23:03:49 tf : 5511 tech fault 5511.2026-01-27 23:03:49 tf : 5510 tech fault 5510.2026-01-27 23:03:49 calibration autozero failed calibration 614.2026-01-27 23:03:47 calibration autozero failed calibration 614.2026-01-27 23:03:47 flow sensor calibration needed alarms.The most probable root cause of the reported event was a defect of the sensor board 2 autozero valves.To correct the issue, a replacement sensor board 2 was sent to the customer.Despite several follow up requests to confirm whether the issue was resolved, no further feedback has been received from the end customer.As no additional information was received, hamilton medical ag considers this case closed.

• Brand Name: HAMILTON-G5
• Common Device Name: HAMILTON-G5
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz
• Manufacturer Contact: roxana huiet ; via crusch 8; bonaduz
• MDR Report Key: 24342700
• Report Number: 3001421318-2026-00066
• Device Sequence Number: 9931057
• Product Code: CBK
• UDI-Device Identifier: 07630002802208
• UDI-Public: (01)07630002802208(11)230221(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,Followup
• Report Date (Section B): 03/02/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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