BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21ST CENTURY MI-1000

    MDR report key: 11742239 · Received April 28, 2021

    Report

    Report Number
    2028295-2021-00004
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAIN #(B)(4) WAS ISSUED FOR A MI-1000 LIGHT SYSTEM OFFERED IN THE 21ST CENTURY PRODUCT LINE (MODEL: 061515 / S/N: (B)(4)). THE UNIT WAS REVIVED AND SENT TO ENGINEERING ON 04/21/2021 FOR FAILURE ANALYSIS. THE CUSTOMER STATED THAT THE LIGHT HAS BEEN IN SERVICE FOR MORE ALMOST (5) YEARS BEFORE THE TRANSFORMER POST FAILED. THE POST (P/N 1002059) WAS REMOVED FOR THE TRANSFORMER ENCLOSURE AND ANALYZED. THE INITIAL REVIEW OF THE POST SHOWED THAT IF FAILED WHERE IT ATTACHES TO THE TRANSFORMER ENCLOSURE. UPON MAGNIFIED VISUAL INSPECTION, THERE WERE NO STRUCTURAL ANOMALIES OBSERVED ON THE POST. THE COLOR FOR THE 12L14 STEEL WAS NORMAL AND THE BREAK HAD NO INDICATION OF STRETCHING OF THE MATERIAL. THE THREADS WERE NORMAL AND SHOWED NO INDICATION OF STRESS. THE LOAD HANDLING CALCULATIONS WERE PERFORMED TO VERIFY THE INITIAL DESIGN PARAMETERS, THE RESULTS EXCEEDED THE STANDARD LOAD-HANDLING GUIDELINES OF A MINIMUM OF SIX (6) TIMES LOAD HANDLING. THE 12L14 STEEL HAS A YIELD OF 60,200 PSI. WE CANNOT DEFINITIVELY DETERMINE A ROOT-CAUSE FOR THIS FAILURE. WHILE A SHARP IMPACT COULD CAUSE THIS CONDITION, NO INDICATION WAS FOUND OF ABUSE OR SIGNIFICANT IMPACT. WE SPECULATE THAT THERE MAY BE A STRUCTURAL DEFICIENCY AT THE QUANTUM LEVEL OF THE STEEL BUT WE DO NOT HAVE THE EQUIPMENT TO IDENTIFY IF MICRO-FRACTURES ARE PRESENT IN THE MATERIAL.

    Description of Event or Problem · 1

    ON APRIL 2ND, IT WAS REPORTED TO MEDICAL ILLUMINATION THAT A 21FT CENTURY MI-1000 HAD BROKE AT THE MOUNTING INTERFACE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639108 21ST CENTURY MI-1000 SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061515

    Patients

    Seq Age Sex Outcome Treatment
    1