MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Deliver (2338)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4)_.Investigation ongoing.
Event or Problem Description
It was reported that the ventilator hamilton-mr1 stopped during ventilation.A burning smell was verbally reported but is not confirmed.The provided logfiles show a technical failure tf 444004.Investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation ongoing.Follow-up 1 - additional information: the entry fields have been updated.The ventilator went into ambient mode and alarmed with tfs during ventilation of a patient.No harm reported.The event did not cause or contributed to a death or serious injury to a patient.The log files confirmed the issue that the device went into ambient mode 2024-09-05 ,17:26:10.The reported event could not be replicated.No correction was performed.After the functional tests passed the device was released back into use.
Event or Problem Description
It was reported that the ventilator hamilton-mr1 stopped during ventilation.A burning smell was verbally reported but is not confirmed.The provided logfiles show a technical failure tf 444004.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 MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: alina valean ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 20349663
• Report Number: 3001421318-2024-02316
• Device Sequence Number: 15480716
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)200616(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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2020
• 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