MAUDE Adverse Event Report: GE MEDICAL SYSTEMS GENERAL ELECTRIC

Model Number GE 1.5T HDX

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/21/2016

Event Type  Injury  

Event Description

Patient developed a burn on upper lateral aspect of right arm during an mri scan of the l-spine.The burn measures approx.2 inches by 2 inches.It appears that the patient's arm came into contact with the bore sometime during the procedure.Patient was instructed by the mr technologists prior to procedure that his skin should not touch the bore of the magnet.The mr technologist was in communication with the patient periodically throughout the procedure, asking him if he was doing "ok" and to let him know the duration of the scan.The patient did not give any indication that he was in distress or feeling any pain or burning during the scan.It was not until after the mri scan was completed that the patient made the mri technologist aware of the burn on his right upper arm.When the patient was asked if he felt anything during the procedure, he stated that he felt it get a little warm, but just wanted to get the scan done.The patient was in the scanner for approx.26 minutes total and received 8 mr sequences totalling 168 images.According to the mr technologist, the patient had non-conductive sheet/padding placed around his upper body for protection before entering the bore of the magnet.In hindsight, it appears that the padding may have slipped down during the procedure at which time it is believed that the lateral aspect of the patient's right upper arm came into contact with the bore of the magnet.There was no metal, tattoos, or other factors present in the area during the scan that would have contributed to the burn.The patient was large in stature and broad through the should area; (b)(6) lbs and 6 ft, 1 inch tall, which is thought to be a contributing factor in this case.Post scan; the patient was seen by our radiology nurse radiologist and wound care nurse for evaluation and treatment.The patient was given an ice pack to place on the burn.Subsequently, silvadene cream and a dressing was applied to burn area.Pt.Was given instructions to keep wound clean and covered with dressing.Dressing supplies and silvadene cream along with ice pack were sent home with pt.Pt was asked to return to imaging dept for follow up check with radiologist and wound care nurse on (b)(6) 2016.

• Brand Name: GENERAL ELECTRIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS; waukesha WI 53188
• MDR Report Key: 5446442
• MDR Text Key: 38657713
• Report Number: 5446442
• Device Sequence Number: 1
• Product Code: CBK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2016,02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GE 1.5T HDX
• Device Catalogue Number: S7505MG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2016
• Distributor Facility Aware Date: 01/21/2016
• Device Age: 9 NA
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2016
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 155