MAUDE Adverse Event Report: HAMILTON MEDCIAL AG HAMILTON-MR1

Model Number	HAMILTON-MR1
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Ventilation stoped when brought to close to mri machine.Unknown patient harm.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDCIAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 16924494
• Report Number: 0002937708-2023-00007
• Device Sequence Number: 6930965
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: 07630002813556
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023
• Report Date (Section F): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HAMILTON-MR1
• Device Catalogue Number: 1610100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2023