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

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/24/2019

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 reported that a patient was having a procedure utilizing a medtronic laser ablation device with a ge healthcare mr system.The patient procedure could not be completed and was reported to have been repeated on a different day.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.The ge mr system is not used to provide the ablation treatment, but rather as an imaging tool to verify that the medtronic catheter was previously positioned correctly during surgery and also to provide imaging during the procedure.During the course of the procedure, the mr system became unavailable due to a component failure.Clinical protocols exist that allow for safe abort of surgical procedures.A review of the system hardware and software logs was conducted.It was found that the mr system became unavailable due to a hardware failure of the scan room power supply (esrps).Prior to the failure, the mr system and esrps were fully operational, with no unusual errors reported in the system error logs.This defect appears to be a unique failure of this off-the-shelf component.The esrps was replaced and the ge mr system is operational.

• 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 53188
• MDR Report Key: 8636974
• MDR Text Key: 145964532
• Report Number: 2183553-2019-00010
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K130115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other