BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS

    MDR report key: 2463416 · Received February 14, 2012

    Report

    Report Number
    2463416
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 20, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    RESIDENT PHYSICIAN PINNED PATIENT IN THE NEWER IMRIS DORO HEADHOLDER. THE PATIENT WAS THEN FLIPPED OVER INTO THE PRONE POSITION. WHILE FASTENING THE HEADHOLDER TO THE BED ATTACHMENT THE HEAD PINS SLIPPED AND MADE A LACERATION ON THE PATIENT'S SCALP. THE PATIENT WAS THEN FLIPPED BACK ONTO THE STRETCHER. AFTER FLIPPING SUPINE ONTO THE STRETCHER A SECOND SUPERFICIAL LACERATION WAS NOTED ON THE OPPOSITE SITE OF THE PATIENT'S HEAD. THE CHARGE NURSE WAS CALLED TO NOTIFY HER OF THE SITUATION. THE DOCTOR THEN IRRIGATED BOTH LACERATIONS WITH NORMAL SALINE MIXED WITH BETADINE. AFTER IRRIGATING, THE DOCTOR STAPLED THE LACERATION CLOSED AND PUT POLYSPORIN OINTMENT TOPICALLY OVER THE STAPLES. HE THEN PUT POLYSPORIN OINTMENT ON THE SUPERFICIAL LACERATION. THE DOCTOR THEN USED THE OLDER HEADHOLDER TO PIN THE HEAD. THE SURGICAL TEAM HELPED TO FLIP THE PATIENT BACK INTO THE PRONE POSITION ON THE SURGICAL BED AND FASTENED THE HEADHOLDER TO THE BED ATTACHMENT WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS HOLDER, HEAD, NEUROSURGICAL HBL IMRIS, INC. 111229-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR