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U.S. Department of Health and Human Services

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

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GE HEALTHCARE MANUFACTURING LLC GE OPTIMA 450W SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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).
 
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Brand NameGE OPTIMA 450W
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE HEALTHCARE MANUFACTURING LLC
MDR Report Key11744562
MDR Text Key248266870
Report NumberMW5101069
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
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 Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5790115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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