MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Smoking (1585); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "technical failure tf 431002 (blower disconnected) and a burning smell was noticed)".The log files indicated that the device switched to ambient mode, technical failure tf 485001 (ambient failure detected).This occurrence was noticed during the pre-operational check.The ventilator device got replaced in the pre-operational stage.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).The investigation is ongoing.Follow-up 1 - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.The log files confirmed the issue.No odor was detected during visual inspection of the device.The root cause of the event was determined to be a defective driver board.After replacing the driver board, the device was released back into use.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "technical failure tf 431002 (blowerdisconnected) and a burning smell was noticed)".The log files indicated that the device switched to ambient mode, technical failure tf 485001 (ambient failure detected).This occurrence was noticed during the pre-operational check.The ventilator device got replaced in the pre-operational stage.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is ongoing.

• 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 MEDIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20503293
• Report Number: 3001421318-2024-02524
• Device Sequence Number: 8380694
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)240412(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/16/2025

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: 1610100
• Device Catalogue Number: 1610100
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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