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

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.

Manufacturer Narrative

H3: ge healthcareâs (gehc) investigation has been completed.A patient received a gunshot wound in the right buttock area when their concealed ferrous handgun was attracted to the magnet and fired a single round.The root cause was determined to be use error.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.Gehcâs mr service safety and installation manuals define the risks associated with entering the scan room with ferrous materials in addition to procedures to follow to maintain controlled access to the mr scan room, and reduce the likelihood of ferrous objects entering it.No further actions are planned by gehc.

• 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 Key: 17404241
• MDR Text Key: 319833434
• Report Number: 2183553-2023-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091536
• Number of Events Reported: 1
• 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

• 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
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 65 KG