BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FONAR INDOMITABLE AKA UPRIGHT MRI

    MDR report key: 758733 · Received September 7, 2006

    Report

    Report Number
    2432211-2006-00001
    Event Type
    Injury
    Date Received
    September 7, 2006
    Date of Event
    July 21, 2006
    Report Date
    September 7, 2006
    Manufacturer
    FONAR CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K002490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SCANNED WHILE SITTING, AND THE TECHNOLOGIST, IN SPITE OF CAUTION LABELS ON THE BED SLAB, PRIOR APPLICATIONS TRAINING AND USER GUIDE INSTRUCTIONS REGARDING USE OF PROTECTIVE PADDING ON ANY EXPOSED METAL ON THE BED AND COIL SURFACES, REMOVED THE BED PAD AND PROCEEDED WITH THE SCAN RELYING SOLELY ON THE PATIENT GOWN AS THE BARRIER BETWEEN THE PATIENT'S SKIN AND METAL CONTACTS ON THE SURFACE OF THE BED SLAB. 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. TO FURTHER REDUCE THE POTENTIAL RISK IF A SIMILAR USER ERROR WERE TO OCCUR, WE ARE NOTIFYING EFFECTED SITES OF THE INCIDENT AND INSTITUTING A FIELD CORRECTION REVISING THE LABELING AND PROVIDING PROTECTIVE COVERS TO PREVENT CONTACT WITH THE EXPOSED CONTACTS IF THE PADDING IS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SCHEDULED FOR AN UPRIGHT MRI OF THE HEAD IN 2006. BECAUSE OF THE PATIENT'S SIZE AND CONTRACTURES, THE TECHNICIAN MADE THE DECISION TO DO THE SCAN WITHOUT PADDING. AFTER THE SCAN WAS COMPLETED AND THE PATIENT WAS LEAVING THE EXAM ROOM, A FAMILY MEMBER OBSERVED DISCOLORATION ON THE BACK OF THE PATIENT'S SHIRT. WHEN CHECKING THE PATIENT'S BACK AND SKIN, TWO 3RD DEGREE BURNS WERE NOTED ON THE PATIENT'S BACK ABOUT THE SIZE OF A 50CENT PIECE. PATIENT WAS TAKEN TO THE ER, CHECKED BY A PHYSICIAN, AND TREATED WITH SILVADENE OINTMENT. PATIENT FOLLOWED UP IN PHYSICIAN OFFICE THREE DAYS LATER AND WAS SCHEDULED FOR PLASTIC SURGERY TO REPAIR WOUNDS TWO DAYS LATER.

    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 44 YR Required Intervention