MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. SIEMENS SKYRA 3T; COIL, MAGNETIC RESONANCE, SPECIALTY

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 03/09/2023

Event Description

Level 1 mr employee was removing qa/qc tools and failed to keep "mri unsafe" cart outside of zone 4.The cart pulled into the magnet with one of the baskets entering the bore.The employee involved in the event received a minor laceration to the left side of his head when the basket flew into the magnet.No other injuries.

• Brand Name: SIEMENS SKYRA 3T
• Type of Device: COIL, MAGNETIC RESONANCE, SPECIALTY
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
• MDR Report Key: 16529614
• MDR Text Key: 311219707
• Report Number: MW5115675
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2023

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1