BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 3487700 · Received November 6, 2013

    Report

    Report Number
    3003807210-2013-00002
    Event Type
    Other
    Date Received
    November 6, 2013
    Date of Event
    October 8, 2013
    Report Date
    November 1, 2013
    Manufacturer
    IMRIS, INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE HOSPITAL LEAD MRI TECHNICIAN REPORTED TO IMRIS THAT DURING THE END OF A PROCEDURE A PATIENT'S HEAD SLIPPED FROM THE HFD100 SKULL CLAMP ASSEMBLY CAUSING A LACERATION ON THE PATIENT'S SCALP. THERE WERE NO OTHER COMPLICATIONS REPORTED. AN IMRIS CUSTOMER SUPPORT SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE TO CONDUCT AN INSPECTION OF THE SKULL CLAMP ASSEMBLY. NO MALFUNCTION OR DISCREPANCIES WITH THE DEVICE WERE OBSERVED. THE SKULL CLAMP ASSEMBLY WAS RETURNED TO IMRIS FOR FURTHER ROOT CAUSE INVESTIGATION. ON (B)(6) 2013, IMRIS PERSONNEL PERFORMED AN EVALUATION OF THE DEVICE. NO MALFUNCTION OR DISCREPANCIES WERE FOUND AND THE DEVICE PERFORMED AS INTENDED. BASED ON THE RESULTS OF THE INVESTIGATION ROOT CAUSE HAS NOT DETERMINED. PINNING TECHNIQUE DURING DEVICE USE IS A POSSIBLE CAUSE OF THE SLIPPAGE; HOWEVER, DATA IS NOT AVAILABLE TO ASSESS THE SPECIFIC APPLICATION OF THE SKULL CLAMP TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572655 IMRIS HFD100 SKULL CLAMP ASSEMBLY HEAD FIXATION DEVICE SKULL CLAMP HBL IMRIS, INC. HFD100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK