MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Investigation ongoing.
Event or Problem Description
Hamilton medical ag received the following description: according to the complaint, the pretests of the ventilator passed.However, when the ventilation was initiated on patient, there was no visible sign of chest movement.Return tidal volumes were 30-50ml when the ventilator was set at 400ml.The ventilator was exchanged, and the patient had normal chest movement and return tidal volumes were correct.No harm to the patient was reported.
Additional Manufacturer Narrative
Follow-up 1: investigation outcome.Upon reviewing the device logs, it was noted that ventilation was initiated in (s)cmv+ mode, but within less than five seconds, the ventilator triggered alarms indicating a patient-side disconnection, low minute volume, and low tidal volume.Although the device was switched to standby multiple times in attempt to resolve the issue and pre-operation checks were completed successfully, the issue persisted.Each attempt to restart ventilation resulted in the same disconnection alarm within seconds.Notably, there were no alarms related to inspiratory volume limitation or pressure limitation in the device logs.The device had last been serviced in august 2024.Device settings at the time of event: 447|2025-07-01 06:38:52|control |vt => 400.0 ml.453|2025-07-01 06:38:52|alarm |vt (low) => 280.0 ml.454|2025-07-01 06:38:52|alarm |vt (high) => 850.0 ml.457|2025-07-01 06:38:52|alarm |plimit => 30 cmh2o.458|2025-07-01 06:38:52|alarm |pressure (low) => 5 cmh2o.459|2025-07-01 06:38:52|alarm |pressure (high) => 40 cmh2o.464|2025-07-01 06:38:52|mode |standby => (s)cmv+.The local service engineer tested the device using three different ventilation modes that may have been in use at the time of the reported event.The tests were performed using a 1 l test lung.No issues were detected during testing, and the device was confirmed to be functioning properly.The reported problem could not be reproduced.Based on the available information, this case is considered closed.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• 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: 22505268
• Report Number: 3001421318-2025-00693
• Device Sequence Number: 15778835
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)240807(240)1610100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153046
• 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): 04/03/2026

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: 1610100
• Device Catalogue Number: 1610100
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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