MAUDE Adverse Event Report: HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP HITACHI OASIS 1.2 TESLA MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Radiation Burn (1755); Skin Irritation (2076); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Pt had belly pain after having mri left shoulder on open mri hitachi oasis 1.2 tesla mri machine.Technologist looked at pt saw redness over abdomen; had pt seen by dr (b)(6) and dr (b)(6).Pt instructed to put bacitracin on area and if the area became more red or developed blisters or oozing of skin return to (b)(6) or be seen by her physician.Called pt approx 5 hours post mri to check status and she had developed a blister; she was asked if she went to (b)(6) and she did not but was again instructed to go to er or call her dr to seek treatment.Pt arrived (b)(6) 2019 at 12:30 here at (b)(6) er to be seen for burn.Fda safety report id# (b)(4).

• Brand Name: HITACHI OASIS 1.2 TESLA MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP
• MDR Report Key: 8992143
• MDR Text Key: 157891350
• Report Number: MW5089701
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 220