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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 07/01/2020
Event Type  Injury  
Event Description
Patient called to report an adverse event involving an mri machine.Patient stated she was having a bilateral breast scan, and just before going into the machine she felt a crushing feeling.Patient stated she screamed and wanted to get out.The medical professional pushed a button and was able to get her out of the machine.The day after the event, the patient said she couldn't breathe and went to the er where she discovered she had a fractured spine and broken ribs with lung involvement.Patient stated she tried to get the incident report that was filed with the facility, but they will not give her the report.Patient stated she was given three reasons why the incident occurred, first was an advance button was used instead of manual, second was the machine locked, third was the mri machine went off track.Patient is very concerned this could happen again and would like the facility and device investigated.
 
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Brand Name
MRI MACHINE
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key10493465
MDR Text Key205707663
Report NumberMW5096415
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 Patient
Type of Report Initial
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age68 YR
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