MAUDE Adverse Event Report: TOSHIBA / CANNON MEDICAL SYSTEMS CORPORATION TOSHIBA MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE

Model Number VANTAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erythema (1840)

Event Date 06/05/2019

Event Type  Injury  

Event Description

Pt had an mri scan of her hips.Her left arm was against the coil connections.Following the scan she reported an area on her left inner arm that was red and warm.Fda safety report id# (b)(4).

• Brand Name: TOSHIBA MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE
• Manufacturer (Section D): TOSHIBA / CANNON MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 8847856
• MDR Text Key: 153104298
• Report Number: MW5088582
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VANTAGE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 79