BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8609538 · Received May 14, 2019

    Report

    Report Number
    2028295-2018-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    October 25, 2017
    Report Date
    January 23, 2018
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT FROM CUSTOMER COMPLAINT # (B)(4) WAS RECEIVED AND AN INVESTIGATION WAS INITIATED. A VISUAL INSPECTION SHOWED THAT THE ARM SUPPORT FITTING (P/N 1002036) FAILED WITH NO OTHER APPARENT DAMAGE. WE PERFORMED A STRUCTURAL ANALYSIS IAW FAILURE ANALYSIS OF THE MI-1000 DATED 07/16/2015. WE REVIEWED THE POROSITY OF THE MATERIAL AND FOUND NOTHING IRREGULAR. THE PRODUCT WAS REBUILT SO WE COULD PERFORM CAPACITY TESTING. THE UNIT PASSED A 6X LOAD TEST FOR 24+ HOURS. WE WERE UNABLE TO DETERMINE THE REASON FOR THE FAILURE. THE POTENTIAL FOR MISUSE IS ALWAYS PRESENT BUT WE WERE UNABLE TO DEFINITIVELY TIE THIS FAILURE TO ANY ABUSE OR MISUSE. THIS BRAKEAGE IS UNUSUAL AS THIS WAS THE ONLY REPORTED BRAKEAGE OF THIS TYPE OF THE (B)(4) ARMS SHIPPED IN 2015. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMDR INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2017 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN MI-1000 ARM SUPPORT FITTING FRACTURED CAUSING THE LIGHT TO FALL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401727 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTERNATIONAL INC. 061515-V

    Patients

    Seq Age Sex Outcome Treatment
    1