BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION EXCEL

    MDR report key: 4943577 · Received July 22, 2015

    Report

    Report Number
    2028295-2015-00001
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 12, 2012
    Report Date
    July 21, 2015
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Product Code
    LBI
    PMA / PMN Number
    K010495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT AND ARM WERE RETURNED TO THE FACTORY FOR ANALYSIS. UPON ARRIVAL, THE ARM SUPPORT FITTING WAS INSPECTED FOR POROSITY AND/OR VOIDS IN THE MATERIAL. NO ANOMALIES IN THE MATERIAL WERE FOUND. THE ARM SUPPORT MATERIAL WAS ALSO IDENTIFIED THAT IT WAS THE SPECIFIED MATERIAL. ADDITIONAL TESTING OF NEW PRODUCT WAS PERFORMED TO VERIFY PRODUCTION PARTS PERFORMED AS DESIGNED. UNABLE TO DETERMINE EXACT CAUSE OF THIS FAILURE. WILL MONITOR FOR ANY FUTURE OCCURRENCES. THE ARM SUPPORT COMPONENT WAS PUT UNDER TEST WITH A 6X LOAD TO CONFIRM THE INITIAL LOAD HANDLING CAPACITY. THIS TEST WAS CONFIRMED AS POSITIVE AND THE CASE WAS CLOSE WITH THE REPLACEMENT OF THE LIGHT ON (B)(4) 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN EXCEL LIGHT ARM SUPPORT FITTING FRACTURED CAUSING THE LIGHT TO FALL HITTING THE DOCTOR ON HIS BACK. THE LIGHT FELL WHEN BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477103 CENTURION EXCEL MINOR SURGICAL LIGHT LBI MEDICAL ILLUMINATION INTERNATIONAL, INC. 061514

    Patients

    Seq Age Sex Outcome Treatment
    1