MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number H866031

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving with sys/mr/oasis open+vertex ii.It was reported that the c-spine coil was used on a patient on tuesday (b)(6) 2023, and the patient has redness in the chest area.It was later reported that the patient did not seek medical treatment.Patient later confirmed that the redness went away.The coil was not touching the patients chest.There was no death associated with the event.

Manufacturer Narrative

Hcus engineer has talked to the technologist who stated that patient had redness to her chest area.The tech stated that the patient was getting scanned and that her chest was getting hot.Tech stated that she was very claustrophobic.The sagittal images were being scanned.Tech pulled her out of the gantry.She did not complete her study.Patient returned on (b)(6) 23 to complete her study.She had no issues that day, except still feeling claustrophobic.No reaction noted by the patient.She was able to complete the rest of her study.Tech stated that the patient had gone to the dermatologist to get it diagnosed after the incident.Dermatologist told her that it could have been some allergic reaction.

• Brand Name: OASIS MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 18065183
• MDR Text Key: 327282350
• Report Number: 1528028-2023-00010
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)170202(250)G210004417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H866031
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 58 KG