MAUDE Adverse Event Report: GE GE 450 W 1.5 T MRI

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 12/18/2017

Event Type  Injury  

Event Description

Pt was transported from his inpatient room to radiology mri room 1 with no events occurring.The pt was ordered under anesthesia due to the pt's preexisting developmental delay and being unable to tolerate an mri without the anesthesia.Anesthesia was able to put the pt under anesthesia with no difficulties.The pt was provided with protective mri safe cushions between his arms and the mri scanner as a standard precaution for the exam.The pt was placed into the scanner.The brain was the first exam, transitioning to lumbar spine, then to the cervical spine.When te table would need to move for the exam, the mri technologist would enter the room to ensure a smooth transition to the next table position.The pt also had his vitals being monitored by the nurse anesthetist, which appeared to go smoothly and without complication.The mri tech monitored the pt's sar level (specific absorption rate, which is the rate that a pt's body will absorb heat during the scan due to the friction within their molecules of the body) which were normal.The pt was also monitored between table movements to ensure he was not overheating.Pt did not feel to have an elevate body temperature.A fan was turned on during the test due to the length of the exam (roughly 3 hrs) to aid with regulation of body temperature.The exam also entailed an injection of contrast media, gadolinium, which seemed uneventful.Images were checked by our radiologist to ensure diagnostic quality.The exam was then complete.Upon conclusion of the exam, the pt was being transferred to pacu for recovery due to his preexisting conditions.During transport, the pt's mother observed a small blister on the pt's right first digit.Once the pt arrived in pacu, a review was completed and another blister on the pt's right lower back was noted.Hospitalization was not prolonged nor was there required intervention to prevent permanent damage.(b)(4) the vendor was contacted on 12/20/2017 and is in-house reviewing the mri.

• Brand Name: GE 450 W 1.5 T MRI
• Type of Device: MRI
• Manufacturer (Section D): GE
• MDR Report Key: 7142236
• MDR Text Key: 95747456
• Report Number: MW5074194
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• 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 Age: 32 YR
• Patient Weight: 87