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

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

Patient Problems Excessive Tear Production (2235); Injury (2348)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi not required.There are no additional device identification numbers.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 initially reported that the customer's service personnel brought a ferrous object into the magnet room.The force of the object being attracted to the magnet pulled the individual's arm.The individual sought medical evaluation, however no serious injury had been confirmed and there was no medical intervention reported.The individual did not provide any further information regarding this event despite multiple attempts by ge healthcare.On 1 april 2019, additional information was received that the individual underwent surgery on (b)(6) 2019 for a partial tear of the left distal biceps tendon and cubital tunnel syndrome.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.The incident was determined to be due to inattentive behavior by the customerâ¿¿s service member bringing a large ferrous object into the magnet room.The mri scanner has been corrected as the ferrous object has been removed from the magnet.Site employees, including the injured individual, have been trained in magnet safety.In addition, magnet warning signs are posted and visible, and the operator/safety manual is confirmed to be onsite and available to the customer.The manual includes safety information related to working within a magnetic field environment.This information has been reviewed with the customer and no additional actions are planned by gehc.

• Brand Name: GE SIGNA EXCITE 1.5T MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 8544246
• MDR Text Key: 142921533
• Report Number: 2183553-2019-00005
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K041476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 109