MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Initial report.
Event or Problem Description
The following was reported to hamilton medical ag: the ventilator device alerts for low o2.In user mode the o2 set value could not be reached or it takes to long before reaching it.There is patient involvement reported but is not further specified.The issue did not result in any patient harm.There is no need for any medical intervention reported.Worst case, a low o2 flow could lead to severe desaturation (spo2 <80%).
Additional Manufacturer Narrative
Hamilton medical ag reference number: (b)(4).Follow-up 1 - complaint investigation.According to the complaint description, the o2 readings were too low (vent set to 61% o2 and was only delivering 45%) during the ventilation of a patient.No harm to the patient was reported.The mr1 unit was returned to the birmingham, where an engineer installed a new mixer assembly and preformed the testing.The device passed all the test.The unit was then sent back to the customer.However, on february 5th, the customer reported low o2 readings once again, but only in user mode.Further investigation using the service software in system test mode revealed that the vent was taking an excessive amount of time to reach the target o2 concentration.For instance, when set to 61%, the reading would stabilize around 57¿58% and remain there for several minutes.Qvent and qo2 flow readings were correct.In the user mode, while operating in pcv+ mode with o2 set to 50%, the system would only reach 44% and trigger a low o2 alarm before eventually climbing to 45%.It also could be noticed that the top section of the blower could rotate fairly easy, likely resulting in inaccurate o2 readings.The original o2 mixer assembly was reinstalled, and the blower was replaced.The most likely reason for the first repair not solving the issue is due to a blower misalignment.Once the original o2 mixer assembly was reinstalled, and the blower was replaced, the issue was resolved.The device completed all calibrations, tests and electrical safety test.

• 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: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 21468124
• Report Number: 3001421318-2025-00345
• Device Sequence Number: 18348541
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)191016(240)161010
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 161010
• Device Catalogue Number: 161010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2019
• 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