MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number OASIS

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

Patient Problems Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688); Partial thickness (Second Degree) Burn (2694)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

The oasis is a 1.2 tesla vertical field (open) mri system.Hitachi service performed thermal testing on the unit and confirmed that the machine is working within specification and there is no evidence of a malfunction.The patient's skin was not touching the top transmitter and the technologist used sufficient padding and operated the system according to ifu and operator manual.Patient was positioned properly and image evaluation indicated good image quality.The sar level is within normal specification.No other patient was injured and no other burn incident occurred with the same system.

Event Description

On (b)(6) 2019, hitachi received a complaint regarding the oasis mri.The site reported that a patient received a lumbar scan on (b)(6) 2019 with the tr body coil and two days later, the patient contacted the site and stated she had a burn on her face.The chief technologist reported that the patient felt like she was having a hot flash and warming sensation during a t2 sagittal.The technologist stopped the scan and waited for her to feel better and then continued the rest of the protocol asking her in-between if she is feeling the sensations and she stated she felt fine after every check.The patient stated there was a sunburn on her face the day after her exam.She noticed swelling and followed up with her pcp and was prescribed prednisone.The patient also followed up with a dermatologist on (b)(6) 2019.

• Brand Name: OASIS
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): HITACHI LTD. HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: jessie san ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 8699434
• MDR Text Key: 148004563
• Report Number: 8030405-2019-00005
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 127