MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159001
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following description: the ventilator alarmed with tf5510 and 5511 during standby.No patient involvement.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.According to the information received, the device generated technical fault alarms 5511 and 5510.Hamilton medical ag received the device logfiles for analysis, in which the reported issue can be observed.2025-06-06 22:20:46 tf : 5511 tech fault 5511.2025-06-06 22:20:46 tf : 5510 tech fault 5510.2025-06-06 22:20:45 calibration autozero failed calibration 614.2025-06-06 22:20:45 calibration autozero failed calibration 614.According to the service manual for the hamilton-g5, the technical faults indicate the following: tf5511 - the pflow sensor signal has been outside the range of 0 v ± 0.6 v when the flow sensor autozero valves open to ambient air during autozeroing.(if the first autozero calibration is faulty, the ventilator immediately repeats the calibration.).Tf5510 - the psensor signal has been above 8.75 v on two consecutive occasions, indicating that one or both autozero valves are not switching.(if the first autozero calibration is faulty, the ventilator immediately repeats the calibration.).It is important to mention that no patient was involved in the event.However, if the event occurs during ventilation, the therapy might be affected and therefore a potential deterioration in the patient's state of health cannot be excluded.Therefore, the event is considered as reportable.The root cause was identified as a defective sensor board, which was subsequently replaced.After the replacement, the device operated as intended.The unit successfully passed all functional tests and was put back in the icu (intensive care unit).

• 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: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 23012916
• Report Number: 3001421318-2025-00791
• Device Sequence Number: 15869438
• Product Code: CBK
• UDI-Device Identifier: 07630002800013
• UDI-Public: (01)07630002800013(11)160509(240)159001
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2016
• 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