MAUDE Adverse Event Report: MONTERIS MEDICAL ATAMA SYSTEM; ATAMA PATIENT BOARD

Model Number	20609
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During the transfer of the patient from the atama board to the mri bed, the mri tech broke a finger when it was in between the atama board and the mri bed.
Additional Manufacturer Narrative
The product was not returned and remains functional at the site.It was reported that an mri technician broke her right ring finger during the transfer of the atama board to the mri bed.The patient was on the board during the transfer.Her finger was wedged between the atama board and the mri bed.The force caused by weight of the patient on the board caused her finger to break.This event occurred because ifu/training instructions were not followed when placing the board.The tech lifted the atama board from the plastic part and did not use the black handle.It was also reported that the tech was a new employee, so they may not have had as much experience.This event did not impact the case.

• Brand Name: ATAMA SYSTEM
• Common Device Name: ATAMA PATIENT BOARD
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th avenue n; suite c; plymouth MN 55447
• MDR Report Key: 11693755
• Report Number: 3009970070-2021-00008
• Device Sequence Number: 11674123
• Product Code: MOS
• UDI-Device Identifier: 00816589020229
• UDI-Public: 00816589020229
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 20609
• Device Catalogue Number: ATB002-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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