MAUDE Adverse Event Report: GENERAL ELECTRIC HEALTHCARE MANUFACTURING, LLC. SIGNA HDX 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING; MRI MACHINE

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

Mri machine stopped working during study.Error message received.Body coil was replaced.(b)(4).

• Brand Name: SIGNA HDX 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: MRI MACHINE
• Manufacturer (Section D): GENERAL ELECTRIC HEALTHCARE MANUFACTURING, LLC.
• MDR Report Key: 15445970
• MDR Text Key: 300300752
• Report Number: MW5112095
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male