MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC GE OPTIMA 450W; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 5790115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/24/2021

Event Type  Injury  

Event Description

Patient received a burn from cardiac monitoring wires tucked under the patient leg.Patient received a 1mm in diameter burn and was treated from the emergency department.Patient was admitted and had surgical relief from a spinal stenosis condition and was also treated for burn during admission.Fda safety report id # (b)(4).

• Brand Name: GE OPTIMA 450W
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 11744562
• MDR Text Key: 248266870
• Report Number: MW5101069
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5790115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 103