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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T; NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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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 Key8636974
MDR Text Key145964532
Report Number2183553-2019-00010
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
PMA/PMN Number
K130115
Number of Events Reported1
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 Received05/23/2019
Supplement Dates Manufacturer Received09/13/2019
Supplement Dates FDA Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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