MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Insufficient Cooling (1130); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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: hamilton medical ag received the following incident description: "the ventilator device failed for the check valve and leak tests.The fan is defective".The issue did not result in any patient harm.When a ventilator device doesn¿t start-up that could lead to desaturation (spo2 80-87%) what makes this case reportable.
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Investigation outcome.It was reported that the device fan is defective, the check valve and leak test also fail.It is important to note that no patient was involved; therefore, no clinical impact occurred.The most likely root causes is a mechanical failure within the fan and a defective check valve assembly.As corrective actions, the fan and the check valve assembly were replaced.Following replacement of the components, the device was fully calibrated and confirmed to function as intended, after which it was returned to use.Hamilton medical ag considers this case 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: albert beckers ; via crusch 8; bonaduz
• MDR Report Key: 21431870
• Report Number: 3001421318-2025-00326
• Device Sequence Number: 11852443
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)230503(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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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