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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC GE 1.5 TESLA SIGNA EXCITE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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GE HEALTHCARE MANUFACTURING LLC GE 1.5 TESLA SIGNA EXCITE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2019
Event Type  No Answer Provided  
Event Description
Mri safety incident. Pt was properly screened with form and verbally prior to entering mri scan room for mri rt shoulder. Once localizer was obtained a metallic foreign body was noted on anterior rt shoulder superficially. Technologist informed mrso immediately. Mrso directed technologist to check pt's gown and coil to make sure nothing metallic was on them. Tech confirmed and removed headphones per mrso. Tech scanned localizer again and artifact was still present. Radiologist was called and looked at localizer images. The radiologist was informed pt had previous mri cervical at same facility prior to the test with no issues. Radiologist found ct chest from another facility and stated the foreign body was too small and superficial to be worrisome and gave authority to continue the exam. Pt did not experience any issues. Fda safety report id # (b)(4).
 
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Brand NameGE 1.5 TESLA SIGNA EXCITE
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE HEALTHCARE MANUFACTURING LLC
MDR Report Key9075741
MDR Text Key158982278
Report NumberMW5089812
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
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 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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