BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS NEURO II-SE

    MDR report key: 2856450 · Received December 3, 2012

    Report

    Report Number
    3003807210-2012-00005
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    August 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K071099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN AN IMRIS NEURO II-SE SUITE ON THE DIAGNOSTIC TABLE PROVIDED BY (B)(4). THE DIAGNOSTIC TABLE IS ATTACHED TO THE (B)(4) ESPREE MAGNET ((B)(4)) AND IS USED UNMODIFIED IN THE IMRIS SYSTEM.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED IN AN IMRIS NEURO II-SE SUITE ON THE DIAGNOSTIC TABLE PROVIDED BY (B)(4). THE DIAGNOSTIC TABLE IS ATTACHED TO THE (B)(4) ESPREE MAGNET ((B)(4)) AND IS USED UNMODIFIED IN THE IMRIS SYSTEM. THE MR TECHNOLOGIST, AFTER COMPLETING A SCAN ON A "LARGE" MALE PATIENT (WEIGHT AND AGE WITHHELD), MOVED THE TABLE OUT OF THE MAGNET, UNSTRAPPED THE PATIENT AND MOVED AROUND TO THE OTHER SIDE OF THE TABLE TO PULL THE PATIENT ONTO THE STRETCHER, AND WHILE WALKING AROUND TO THE OTHER SIDE, THE PATIENT ROLLED OFF FROM THE BED, STRIKING HIS FOREHEAD ON THE PEDESTAL OF THE TABLE. BEFORE THE SCAN THE PATIENT WAS SLIGHTLY CONFUSED AND RESTLESS SO HAD BEEN GIVEN MEDICATION PRIOR TO THE SCAN TO HELP THEM STAY STILL. AFTER THE MEDICATION THEY WERE STILL ALERT. THE PATIENT SUSTAINED FOREHEAD LACERATION OF APPROXIMATELY 2.5 CM, WHICH REQUIRED PLASTIC SURGERY TO PERFORM COMPLEX CLOSURE. THE PATIENT ALSO SUSTAINED BLEEDING IN THE BRAIN. (B)(4) INVESTIGATED THE ISSUE AND DETERMINED THAT THE TABLE WAS OPERATING PER SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE IMRIS NEURO II-SE INTRA-OPERATIVE MR SYS LNH IMRIS, INC. NEURO II-SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L