MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH SIEMENS MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number IMAGNETOMVERIO 3.0T

Patient Problems Peeling (1999); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 10/16/2023

Event Type  Injury  

Event Description

(b)(6) had a mri (magnetic resonance imaging) with and without contrast of his left femur under general anesthesia.During the mri the mri technologist received an alert that stated they had 60 seconds to get patient out of the mri bore before the mri machine's power would shut off.The mri techs went to get patient off table, but the mri/table shut-off before they could remove the patient from the bore.The mri techs manually released the table and then pulled the table out of the bore with the patient on it.When the patient was out of the bore, it was noted, on assessment, that the patient had a wound to the right elbow that looked like a blister and the skin peeled off.The wound was cleaned with soap and water and a dressing was applied.The patient was referred to (b)(6) center for follow-up.Patient was assessed at (b)(6) center on (b)(6) 2023.The wound was assessed and noted to be a bum, with serosanguineous drainage, measuring 3.9 cm in length, 3.4cm in width, and 0.1 cm in depth.The mri was serviced on 10/16/2023.The following information was noted on the field service report: reason for service- equipment shut down with patient under anesthesia.Corrective action/service performed- system shut down due to gradient temperature errors when scanning a patient 350ibs and up.System showed sequence protocol error.Vlm was reset and there were no flipped breakers or signs of any burn damage.Tools for gradients x,y,z and gpa status all passed.Head coil was used for a scan and the images were good.Sep cabinet water levels were all good and system temperatures were normal.

• Brand Name: SIEMENS MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 18211691
• MDR Text Key: 329262149
• Report Number: MW5148517
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006666
• UDI-Public: 4056869006666
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMAGNETOMVERIO 3.0T
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 157 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American