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

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Bilateral burns post mri.Elderly female with history of diabetes and chronic lymphedema underwent an mri of the foot on [redacted date].During follow-up her provider identified burns on the dorsum of patient's both hands which the patient reports began to redden the day following her mri.She states they do not hurt and she has been applying an otc cream, no other treatment.Manufacturer response for mri scanner, (brand not provided) (per site reporter) unknown by this reporter other than that the responding (covering) service manager said he would notify our service engineer.

• Brand Name: ESPREE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode 65-1a; malvern PA 19355
• MDR Report Key: 16775482
• MDR Text Key: 313639429
• Report Number: 16775482
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/14/2023,04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2023
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31025 DA
• Patient Sex: Female
• Patient Race: White