MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-G5

Model Number	159002
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hamilton medical ag received the following event description: it was reported that during pm the device alarms with disconnection on patient side and autocycles.No health consequences or impact.
Additional Manufacturer Narrative
Hamilton medical ag ref.Nr: (b)(4).Investigation ongoing.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Hamilton medical ag received the logfiles for analysis.The provided logfiles show that on 26.01.2026 the logfiles were downloaded.Further it can be seen that the device was not in use for around 3 months.The reported alarm "disconnection on patient side¿ can be seen frequently during patient ventilation until the device was switched off at 28.10.2025.No tfs were logged."disconnection on patient side" happened during ventilation before the service technician performed the preventive maintenance.The event log shows a high frequency of patient disconnection alarms, low tidal volume , loss of peep, and low minute volume alarms , consistent with significant leakage or flow instability.Additional occurrences of ventilator-side disconnection and flow/volume-related alarms further support intermittent circuit integrity issues rather than a purely transient event.No patient harm was reported despite patient involvement before preventive maintenance.A servo module sent to customer to address the reported issue.The manufacturer has not received any further information, nor have we received any further complaints about this device, so it is assumed that the problem has been solved after replacing the servo module 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: alina liliana valean ; via crusch 8; bonaduz
• MDR Report Key: 24231768
• Report Number: 3001421318-2026-00043
• Device Sequence Number: 13305805
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 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: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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