MAUDE Adverse Event Report: GE GE HDX

Model Number GE HDX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Radiation Burn (1755); Unspecified Infection (1930)

Event Date 05/11/2017

Event Type  Injury  

Event Description

The patient was sedated for mri scans of the lumbar and pelvis by dr (b)(6).The patient was padded along her arms as well covered with sheets and arms drawn tight to allow patient to fit into scanner as well keep them from rubbing against the sides of the bore.The patient was then drawn out of the magnet at the request of dr (b)(6) to readjust some of the monitoring equipment.The padding again placed and patient arms secured and the patient was again placed into the scanner.The lumbar scan w\o portion of the scan was then carried out without incident.The patient was then brought out of the scanner to change out coils to begin the pelvic scan.At this point i checked on the patient including checking her arms for heating and found that none was occuring.The coil was changed out and the patient again placed onto the table to resume scanning of the pelvis.Multiple breaks were taken during the pelvis portion of the exam to adjust scanning parameters and once to confer with a supervisor about adjusting parameters the w\o portion was completed.At this point i pulled the patient out to administer contrast.Once i had the patient out of the scanner i again checked for any signs of heating and found that she was very warm on her right arm around her elbow.At closer inspection i found her arm to show signs of significant burns.I then called my supervisor, (b)(6), for guidance.He instructed me to consult a radiologist.I called dr (b)(6) who was at (b)(6) and informed him of the situation.After giving her the details and letting him also speak with dr (b)(6) who stated that he did not believe that the patient could not be padded any better to avoid further injury.It was determined that the test should not be proceeded and was at that point terminated.The patient was brought out of the mri suite and extubated and sent to recovery.(b)(6) was again notified of the steps taken as well as lead tech (b)(6).Of note - the patient was believed to have an infection, and she had gotten some saline as well as possibly other meds onto the sheets around her arm in the area of the burns.Both factors that could have also contributed to rapid heating.

• Brand Name: GE HDX
• Type of Device: GE HDX
• Manufacturer (Section D): GE
• MDR Report Key: 6568665
• MDR Text Key: 75344693
• Report Number: MW5069793
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2017

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
• Device Model Number: GE HDX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 103