MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC 1.5T SIGNA HDXT; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Electromagnetic Interference (1194); Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); Loss of consciousness (2418); Tooth Fracture (2428)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi not required.No additional device identification numbers have been received.Information requested but not yet received.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported by the news media in (b)(6) and confirmed by the customer that a male technologist entered the mr scan room of a mobile mri unit wearing a weight vest normally used for exercise.The technologist was attracted to the magnet.The technologist is said to have sustained serious injuries to the head/neck area, lost two teeth and was immediately admitted to the hospital's intensive care unit.It was reported that the patient inside the scanner at the time of the event did not sustain any injuries.The patient heard the technologist scream and saw his hand at the edge of the magnet bore.Realizing that something was wrong, the patient crawled out of the other end of the magnet and was able to exit the mobile van through the service door.The patient alerted two security guards who responded and cut the weight vest off of the technologist, freeing him from the magnet.Both security guards sustained minor injuries.It appears that no damage was caused to the mr system.It was reported that the system was ramped down so that police could conduct an investigation.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The incident occurred due to inattentive behavior by the technologist by bringing a ferrous vest into the magnet/scan room.The technologist was confirmed by the customer to be mr safety trained and the ferrous object warning signs were present at the site.The mr safety guide or the operator manual with integrated safety section clearly defines the risks associated with owning and operating an mr scanner.No additional actions are planned by gehc.

• Brand Name: 1.5T SIGNA HDXT
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 9355186
• MDR Text Key: 167986658
• Report Number: 2183553-2019-00028
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K121676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR