MAUDE Adverse Event Report: HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ESCHELON OVAL

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/18/2021

Event Type  Injury  

Event Description

Patient was undergoing an mri scan of the right hip.When the patient was taken out of the scanner at the completion of the exam, he reported to the technologist that his upper thighs felt like they were burning.Upon inspection of the patient, two small red circles were present on his inner thighs where they were touching, and he had burning pain present in that area.At that time, the patient did not request medical treatment and left the facility.The next day a follow up call was performed.The patient stated the redness was less at the end of the day (day of exam), but there were pin head size blisters on both legs in that area (3 on right and 2 on left) that evening.The next day (3/18) he stated the blisters were scabbed over and improving, and said he was ok.He did not indicate he needed to seek medical treatment.Another attempt was made to contact the patient a week later, but he did not return phone call.Fda safety report id# (b)(4).

• Brand Name: MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP; twinsburg OH 44087
• MDR Report Key: 11596146
• MDR Text Key: 243460462
• Report Number: MW5100427
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESCHELON OVAL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 64 YR
• Patient Weight: 111