MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY MR750 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2023

Event Type  Injury  

Event Description

It was reported that a hospital bed was taken into the scan room when it became attracted to the magnet.A staff member sustained injuries which required medical treatment.

Manufacturer Narrative

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.

Manufacturer Narrative

A1,2, 3, 4, 5, 6: patient information was requested on 27 feb 2023, 28 feb 2023, 06 mar 2023, 14 mar 2023 and 20 mar 2023 but no information has been received.H3: ge healthcare's (gehc) investigation has been completed.A member of the hospital's nursing staff was injured when a hospital bed was attracted to the mr system.The root cause was determined to be use error.Gehc's 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.H6 health effect - clinical code: e20 - injury.

• Brand Name: DISCOVERY MR750 3.0T
• 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: 16592842
• MDR Text Key: 311785444
• Report Number: 2183553-2023-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: 02/23/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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