MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. GE 450W MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Ulcer (2274); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 09/17/2022

Event Type  Injury  

Event Description

Patient was admitted in the hospital and brought down to radiology for mri exams of the thoracic and lumbar spine with a phased array spine coil on a ge 450w 1.5t scanner.Patient is morbidly obese and states that she told the mri staff towards the end of the mri lumbar exam that she felt a burn on her right thigh and asked them to get out of the scanner.The mri team completed the last sequence and pulled her out.Before starting the mri lumbar, the mri technologist confirmed that approved pads were placed between the patient's arms and the bore of the mri machine.She was taken back up to the inpatient floor, shortly after which a hospital supervisor was notified to assess the patient's complaint.A fluid filled blister was observed in the upper right thigh in the lateral posterior aspect.In the following days, the blister did burst and progressed to an open wound ulcer that required treatment and dressing changes on a regular basis.Fda safety report id# (b)(4).

• Brand Name: GE 450W MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.
• MDR Report Key: 15673546
• MDR Text Key: 302492620
• Report Number: MW5112844
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 190 KG