MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag complaint number: cer (b)(4).Initial report:.
Event or Problem Description
The following was reported to hamilton medical ag: hamilton medical ag received the following incident description: "ventilator shutdown during patient use.Patient was in the mri suite and the ventilator stopped actively ventilating.Air was going into the circuit but not reaching the patient.The error message read expiratory flow sensor failure.".It is not known if the device was positioned too close to the mri scanner.There is need for medical intervention reported.Hamilton medical ag has not received any further information on this.No harm to the patient, user or third party has been reported.
Additional Manufacturer Narrative
Follow-up 1 (final) - additional information: the entry fields b4, g6, h2, h3, h6 and h11 have been updated.The following was reported: "patient was in the mri suite and the ventilator stopped actively ventilating.Air was going into the circuit but not reaching the patient.The error message read expiratory flow sensor failure".The patient was then switch to an alternative ventilator.According to the available information, the hamilton-mr1 ventilator was positioned too close to mri magnet.Without the corresponding logfiles, this statement cannot be confirmed but can be deduced from the information available.Based upon the available information the root cause is a user error.

• 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: 20681729
• Report Number: 3001421318-2024-02715
• Device Sequence Number: 18002230
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)221110(240)1610100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/17/2025

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: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown