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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA MR450W; NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC OPTIMA MR450W; NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/28/2023
Event Type  Injury  
Manufacturer Narrative
D: there are no additional device identification numbers.H3, 6: ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that a patient was brought into the magnet room with a concealed ferrous handgun.In the process of entering the bore, the handgun was attracted to the magnet and fired a single round.The patient received a gunshot wound in the right buttock area.The patient was examined by a physician at the site who described the entry and exit holes as very small and superficial, only penetrating subcutaneous tissue.Per protocol, the patient was taken to the hospital and the patient later informed the site that they were okay and healing well.The site reported that prior to the exam the patient had undergone a standard screening procedure for ferrous objects, which includes weapons specifically, and answered no to all screening questions.
 
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Brand Name
OPTIMA MR450W
Type of Device
NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer (Section G)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
andy koch
3200 n. grandview blvd.
waukesha, WI 53188
MDR Report Key17404241
MDR Text Key319833434
Report Number2183553-2023-00002
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient SexFemale
Patient Weight65 KG
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