BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000 DUAL CEILING

    MDR report key: 8609840 · Received May 14, 2019

    Report

    Report Number
    2028295-2018-00003
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED THE RETURNED LIGHT UNDER CUSTOMER COMPLAINT : (B)(4) AND AN INVESTIGATION WAS INITIATED. THE UNIT WAS VISUALLY INSPECTED AND THE ARM SUPPORT FITTING (P/N 1002036) WAS FOUND TO HAVE FAILED. NO OTHER DAMAGE WAS OBSERVED. HAVING SEE A SIMILAR FAILURE WITHIN THE PAST SIX MONTHS, WE PERFORMED MULTIPLE CUT CROSS-SECTION ANALYSIS TO RULE OUT POROSITY AS A CAUSE OF FAILURE. THE MATERIAL POROSITY LOOKED NORMAL AND NO STRESS-RELATED FACTORS WERE FOUND. THE PRODUCT COULD NOT BE CAPACITY TESTED DUE TO THE FAILURE LOCATION SO IT WAS REBUILT AND TESTED WITH A P/N 1002036. WE THEN TESTED THE SYSTEM TO THE FAILURE ANALYSIS OF THE MI-1000 SYSTEM DATED 07/16/2015. THE UNIT PASSED ALL TESTS. WE COULD NOT DETERMINE THE ULTIMATE CAUSE OF THE FAILURE OF THE P/N 1002036. THE LOAD TEST WAS PERFORMED AT 6X AND THE UNIT SHOWED ON DEGRADATION. 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 CAUSING THE LIGHT TO FALL. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403487 MI-1000 DUAL CEILING MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061515-V

    Patients

    Seq Age Sex Outcome Treatment
    1