MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	161010
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: (b)(4).Final report measures taken: the root cause is a defect fan ((b)(6)).The defect fan have been replaced.The ventilator device past the service software tests successfully and is put back in service.
Event or Problem Description
During patient ventilation the hamilton-mr1 ventilator device alerted for fan failure.The issue did not result in any patient harm.There was no need for any medical intervention reported.No device log files were provided to hamilton medical.The issue is not likely to be serious to public health but has potential to cause serious injury or death if it were to recur during the use with a patient.Therefore, the event has been deemed to be a reportable event.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz 7402 ; SZ 7402
• MDR Report Key: 21932705
• Report Number: 3001421318-2025-00573
• Device Sequence Number: 21018427
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: (01)07630002800761(11)220826(240)161010
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 04/17/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown