BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8614077 · Received May 15, 2019

    Report

    Report Number
    2028295-2019-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 15, 2019
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHTING SYSTEM WAS INSTALLED IN A VERTINARIANS EXAMINATION ROOM WITH NORMAL USE AND NO EXTREME INSTANCES REPORTED. THE ARM SUPPORT FITTING COMPONENT (P/N 1002036) WAS NOT AVAILABLE TO THE ENGINEERING GROUP TO PERFORM A ROOT CAUSE ANALYSIS SO THE FOLLOWING ASSUMPTIONS OF THE FAILURE ARE DERIVED ONLY FROM THE PICTURES SUPPLIED FROM THE CUSTOMER. THE PICTURES SHOW SEVERAL THINGS PERTINENT TO THE FAILURE. THE MATERIAL APPEARS TO BE SOLID AND NULL OF ANY VOIDS INDICATION THAT THERE WAS NO POROSITY OR MATERIAL BREAKDOWN. THE MATERIAL APPEARS TO BE CONSISTENT IN COLOR WITH VIRGIN RAW ALUMINUM MATERIAL - NO CONTAMINATION OBSERVED. THE BREAK APPEARS TO BE CONSISTENT AND STRAIGHT INDICATING THAT THIS LIKELY HAPPENED INSTANTANEOUSLY AND NOT OVER A PERIOD OF TIME. THE BREAKING POINT IS LOCATED AT THE THROUGH HOLE ON THE ARM PIVOT POINT. THIS COULD ALSO BE CONSISTENT WITH A SUDDEN IMPACT OF THE ARM ASSEMBLY TO A SOLID OR HARD OBJECT BUT THIS SPECULATION CANNOT BE FULLY SUBSTANTIATED FROM A PHOTOGRAPH. IN RESEARCHING THIS FAILURE WE FOUND TWO (2) OTHER REPORTED FIELD FAILURES WITH SIMILAR VISUAL INDICATIONS. ONE OF THE FAILURES WAS A RESULT OF A HARD IMPACT AGAINST A WALL AND THE OTHER FAILURE OCCURRED WHEN A MEDICAL TECHNICIAN ADMITTEDLY OVER-TIGHTENING THE PIVOT SCREW. BOTH INCIDENTS WERE DEEMED OPERATOR CAUSED. IT IS IMPOSSIBLE TO DEFINITIVELY ASSIGN CAUSE TO THIS ANALYSIS BECAUSE WE DO NOT HAVE THE PHYSICAL COMPONENT THAT FAILED. IT IS ALSO SPECULATION THAT THIS COMPONENT OPERATED NORMALLY WITHIN SPECIFIED RANGE OF NORMAL OPERATION. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMDR INSTEAD OF PRODUCTION. THIS ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS REPORTED TO MEDICAL ILLUMINATION THAT A MI-1000 HAD A BROKEN ARM SUPPORT FITING P/N 1002036 AND WAS SENT IN TO BE REPAIRED. NO INJURIES OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405365 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061515

    Patients

    Seq Age Sex Outcome Treatment
    1