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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC COMPANY GE 3.0T HDXT 23.0 MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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GENERAL ELECTRIC COMPANY GE 3.0T HDXT 23.0 MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Electromagnetic Compatibility Problem (2927)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 06/29/2020
Event Type  Injury  
Event Description
Mri technologist allowed a patient to enter into a 3t mri imaging suite with a ferromagnetic knee scooter.The scooter was pulled to the magnet along with the patient.The patient's thumb was pinched between the handle bars and the magnet face.The patient was able to pull her thumb free and escaped with only a gash in her thumb.The patient refused to be seen by the emergency department physician.The scanner had to be ramped down to remove the scooter from the bore.When the engineers were doing the ramp down the following day the scanner spontaneously quenched.Please note the reporting technologist was not working the day of the event.The technologist who had the event is no longer employed at our facility.Fda safety report id# (b)(4).
 
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Brand Name
GE 3.0T HDXT 23.0 MRI
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GENERAL ELECTRIC COMPANY
MDR Report Key10263490
MDR Text Key198697652
Report NumberMW5095489
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 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
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 Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight53
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