MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. GE MRI COMPUTER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 2156158-143

Device Problem Computer Operating System Problem (2898)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Patient underwent mri imaging of brain, c/spine, l/spine and t/spine.During the edit process, machine failed due to not enough disc space.Images were lost.Fda safety report id# (b)(4).

• Brand Name: GE MRI COMPUTER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.
• MDR Report Key: 13117973
• MDR Text Key: 283139102
• Report Number: MW5106357
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2156158-143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female