BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS

    MDR report key: 7638992 · Received June 26, 2018

    Report

    Report Number
    8030405-2018-00003
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 16, 2018
    Report Date
    May 29, 2018
    Manufacturer
    HITACHI LTD, HEALTHCARE BUSINESS UNIT
    Product Code
    LNH
    PMA / PMN Number
    K093044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 BODY COIL SURFACES AND THE TECHNOLOGIST USED SUFFICIENT PADDING. THE TWO COILS USED ARE PASSIVE, RECEIVE-ONLY DEVICE AND IS NOT CAPABLE OF CAUSING A THERMAL INJURY WHEN WORKING PROPERLY. IMAGE EVALUATION INDICATED NORMAL IMAGE QUALITY. THE SITE DID NOT SEE THE PATIENT AFTER THE REPORT NOR RECEIVED A PHYSICIAN'S REPORT TO CONFIRM THE EXTENT OF THE INJURY. NOTE THAT THE REPORT WAS MADE 10 DAYS AFTER THE EXAM. HITACHI COULD NOT FIND A PROBABLE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A PATIENT'S FAMILY CALLED ON SATURDAY (B)(6) 2018 TO REPORT THAT THE PATIENT WAS CURRENTLY IN THE EMERGENCY ROOM WITH BURNS AND BLISTERS DUE TO AN MRI SCAN DONE ON THE HITACHI OASIS MRI AT (B)(6) RADIOLOGY. THE PATIENT WAS SCANNED ON (B)(6) 2018 FOR BOTH AT THORACIC SPINE AND A LUMBAR SPINE USING RECEIVE-ONLY BODY COILS. AT TIME OF THE MRI THE PATIENT DID NOT COMPLAIN OF ANY DISCOMFORT, NOR NOTE ANY BLISTERING OR BURNING. NO OTHER PATIENTS HAVE NOTED ANY HEATING ON ANY COIL ON THE SYSTEM. (B)(6) REPORTED THE INCIDENT TO HITACHI HEALTHCARE AMERICAS ON 05/29/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480671 OASIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention