MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

Patient information could not be provided due to country privacy laws.There are no additional device identification numbers.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.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 that a mr technologist was assisting a patient into the scan room when all of sudden, while positioning the patient, the son entered the room to try and help.The son (military policeman) had a gun at his waist along with a cell phone.The gun went off and struck the cell phone and then the son in his leg.The gun then became attracted to the magnet.The son was initially treated at the imaging center and then sent to a different hospital where the bullet was removed from his leg.

Manufacturer Narrative

Ge healthcare's investigation has been completed.Based on the information reviewed, the root cause of the injury appears to be an inexperienced technologist that allowed the son to enter the scan room without being properly screened.The mr safety guide or the operator manual with integrated safety section, which is delivered to the customer, clearly defines the risks associated with owning and operating an mr scanner.The site has been corrected, as the ferrous object has been removed from the magnet.(b)(4).

• Brand Name: DISCOVERY MR750W 3.0T
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n. grandview blvd.; waukesha WI
• Manufacturer Contact: jacqui budde ; 3200 n grandview blvd.; waukesha, WI 53188 ; 2625216611
• MDR Report Key: 6492689
• MDR Text Key: 72783054
• Report Number: 2183553-2017-00005
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K132376
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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