MAUDE Adverse Event Report: GE HEALTHCARE MANUFACTURING LLC 1.5 TESLA GE SIGNA ARTIST WIDE BORE MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/12/2023

Event Type  Injury  

Event Description

We had a patient that had an mri lumbar spine without contrast yesterday (b)(6) 2023 around 12:00 noon at our 1.5t ge mri scanner.The patient called today(b)(6) 2023 around 09:00 am to report that she has a dime size burn on her left side of her stomach of her body at about left hip level (pt has a large body habitus and due to that her stomach hangs quite low) and she thinks it is from her mri yesterday.I talked to the patient today when she called this am at about 9am and she said that she had an mri yesterday of her spine and during the mri scan she did feel some burning around her left hip area and did squeeze her call bell to alert the technologist.When the technologist checked in on her she told the technologist that she was having pain/burning sensation in left hip area.The patient said she repositioned her hips and that took the pain/burning sensation away and the patient decided to continue with the mri.I have notified our mri medical director and the patients doctor¿s office.Of note, patient was positioned supine feet first in scanner with her arms above her head (she would not fit in the scanner with her arms down by her sides) and there was sufficient padding used in-between the patient¿s body and the mri gantry (bore of the magnet).There were no cords or monitors attached to the patient or anything electronic attached to the patient.The patient was in her street clothes for the mri as she would not fit into our hospital supplied attire.The tags of the patients clothing were checked pre-mri and both her pants and her shirt she wore during the mri were both labeled as being cotton.

• Brand Name: 1.5 TESLA GE SIGNA ARTIST WIDE BORE MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE MANUFACTURING LLC
• MDR Report Key: 17143510
• MDR Text Key: 317476929
• Report Number: MW5118430
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 199 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White