BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HITACHI OASIS 1.2 TESLA MRI MACHINE

    MDR report key: 8992143 · Received September 10, 2019

    Report

    Report Number
    MW5089701
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 6, 2019
    Manufacturer
    HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780376 HITACHI OASIS 1.2 TESLA MRI MACHINE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH HITACHI LTD., MEDICAL SYSTEM OPERATIONS GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other