BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FONAR INDOMITABLE AKA UPRIGHT MRI

    MDR report key: 1401591 · Received June 12, 2009

    Report

    Report Number
    2432211-2009-00001
    Event Type
    Injury
    Date Received
    June 12, 2009
    Date of Event
    May 15, 2009
    Report Date
    June 11, 2009
    Manufacturer
    FONAR CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K002490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURN SITES WERE IDENTICAL TO ELECTRICAL CONTACTS ON THE PATIENT'S BED. IN SPITE OF CAUTION LABELS ON THE BED AND INSTRUCTIONS IN THE USER MANUAL INDICATING CONTACT WITH THE SKIN MAY INDUCE RF BURNS DURING SCANNING AND REQUIRING THE CONTACTS BE COVERED BY THE PROVIDED SAFETY COVERS OR BED CUSHION, THE PATIENT WAS POSITIONED SO THAT BARE SKIN WAS IN DIRECT CONTACT WITH THE ELECTRICAL CONTACTS. NEITHER THE SAFETY COVERS NOR BED CUSHION WERE USED TO COVER THE ELECTRICAL CONTACTS. WE FEEL THAT THIS IS A CASE OF USER ERROR, AND NOT A DEFECT IN THE DEVICE. IF THE SYSTEM IS OPERATED IN THE CORRECT MANNER, THIS TYPE OF INJURY SHOULD NOT OCCUR TO ANY PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN POSITIONED IN AN UPRIGHT MRI FOR A LUMBAR AND SACRUM EXAM. THE PATIENT CHANGED INTO A PATIENT GOWN WHICH WAS OPEN AT THE BACK AND ENDED AT THE KNEE. THE PATIENT WAS POSITIONED ON THE BED SLAB ON HER BACK WITH A BED CUSHION POSITIONED UNDERNEATH HER. THE CUSHION ENDED AT THE PATIENT'S WAIST. THE PATIENT WAS SITTING ON THE PATIENT SEAT AND THE BED WAS UPRIGHT FOR THE LUMBAR SCAN. THE PATIENT WAS STANDING ON THE PATIENT SEAT IN THE RECUMBENT POSITION, FACE UP, FOR THE SACRUM SCAN. BOTH SCANS WERE COMPLETED WITH NO COMPLICATIONS OR COMMENTS FROM THE PATIENT. UPON LEAVING THE MRI SUITE, THE PATIENT MADE THE COMMENT THAT THE MACHINE BURNED HER. THE TECHNOLOGIST EXAMINED THE PATIENT AND FOUND A RED BURN APPROXIMATELY 5-6 INCHES IN DIAMETER ON THE RIGHT LATERAL CALF, 1-1.5 INCHES BELOW HER KNEE. THE PATIENT SOUGHT MEDICAL ATTENTION FROM HER PRIMARY CARE PHYSICIAN AND WAS FOUND TO HAVE 2 BURNS, ONE OF WHICH WAS A 3RD DEGREE BURN 3/16 INCH IN DIAMETER. THE PHYSICIAN TREATED HER WITH A TOPICAL OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FONAR INDOMITABLE AKA UPRIGHT MRI MAGNETIC RESONANCE IMAGING SCANNER LNH FONAR CORPORATION UPRIGHT MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other