MAUDE Adverse Event Report: GENERAL ELECTRIC DISCOVERY MR 75W; MRI

Model Number DISCOVERY MR 75W

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Event Description

Mri machine quenched while pt was in the unit.No harm to the pt.

• Brand Name: DISCOVERY MR 75W
• Type of Device: MRI
• Manufacturer (Section D): GENERAL ELECTRIC
• MDR Report Key: 7240975
• MDR Text Key: 99102631
• Report Number: MW5075056
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISCOVERY MR 75W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR