BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8659872 · Received May 31, 2019

    Report

    Report Number
    2028295-2019-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 31, 2019
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARM SUPPORT FITTING COMPONENT (P/N 1002036) WAS SENT TO THE ENGINEERING GROUP TO PERFORM A ROOT CAUSE ANALYSIS. THE FAILED FITTING WAS INSPECTED FOR POROSITY, CONTAMINATION OR MATERIAL IRREGULARITIES. NOTHING UNEXPECTED WAS IDENTIFIED. THE SUPPLIER WAS ASKED ON A PREVIOUS INVESTIGATION ABOUT THE MATERIAL AND SAID THAT THE SPECIFICATION AND THE SOURCE OF THE MATERIAL HAVE ALWAYS BEEN THE SAME BUT DID NOT HAVE LOT-SPECIFIC INFORMATION. A 6X LOAD TEST WAS DONE IN THE INITIAL DESIGN AND IN A PREVIOUS INVESTIGATION OF A SIMILAR PART AND THE LOAD TEST WAS DEEMED SUCCESSFUL. AN ABNORMAL WEAR PATTERN ON THE BACK SIDE OF THE FITTING WAS OBSERVED. THIS WEAR PATTERN PHYSICALLY REMOVED THE PAINT ON THE UNIT. THE PAINT BEING WORN OFF OF THE FITTING INDICATES THAT THE ARM ASSEMBLY WAS REPEATEDLY FORCED IN A DIRECTION OR PUT IN A CONDITION THAT THE ARM WAS NOT DESIGNED TO ACCOMMODATE. WE ATTEMPTED TO DUPLICATE THIS WEAR PATTERN ON A SYSTEM AND AFTER NUMEROUS ATTEMPTS OF EXCEEDING THE ROTATIONAL LIMITS WE STARTED SEEING A SIMILAR WEAR PATTERN START TO FORM. THIS INDICATED THAT THIS CONDITION LIKELY CAUSED THE WEARING AND THAT IT HAS BEEN GOING ON FOR A WHILE. THE STRESS APPLIED TO THE ARM TO GET A VERY SMALL PERCENTAGE OF THE SCARING WAS EXCESSIVE BUT NOT QUANTIFIABLE.

    Description of Event or Problem · 1

    ON (B)(6), A CUSTOMER CONTACTED MEDICAL ILLUMINATION TO REPORT THAT THEY HAD AN MI-1000 THAT NEEDED REPAIR FOR A BROKEN ARM SUPPORT FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453736 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061514

    Patients

    Seq Age Sex Outcome Treatment
    1