BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 18439766 · Received January 3, 2024

    Report

    Report Number
    2028295-2023-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    November 30, 2023
    Report Date
    December 29, 2023
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    UDI-DI
    00816835020171
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTMER COMPLAINT #(B)(4) WAS ISSUED FOR AN MI-1000 LIGHT SYSTEM (MODEL: 061525 / S/N: (B)(6). BASED ON A FEW PICTURES PROVIDED TO US, IT APPEARS THAT ALL 3 COUNTER SINK SCREWS THAT SECURE THE DOWN TUB TO THE CEILING MOUNT HAD SHEARED OFF CAUSING THE LIGHT SYSTEM TO FAIL. WE WERE UNABLE TO RETRIEVE ANY SAMPLE MATERIAL FOR EVALUATION. WE CANNOT DEFINITIVELY DERTERMINE A ROOT CAUSE OF THIS ISSUE. THE FORCE NEEDED TO SHEAR ONE 8-32 SCREW IS ROUGHLY 854LBS IN SINGLE SHEAR, SINCE THERE ARE 3 SCREWS AND WITH A FOS OF 5 WE ARE STILL SEEING 500LBS TO FAIL. IF WE ACQUIRE ANY ADDTIONAL INFORMATION ON THIS ISSUE, WE WILL AMEND THIS REPORT AS NECESSARY.

    Description of Event or Problem · 0

    ON NOVEMBER 30TH, IT WAS REPORTED TO MEDICAL ILLUMINATION THAT AN MI-1000 LIGHT SYSTEM HAD SEPARATED FROM THE DOWN TUB TO THE CEILING MOUNT. THE REPORTER ALSO STATED SOMEONE HAD RECEIVED STITCHES. WE WERE UNABLE TO CONFIM THIS DUE TO LOCATION (SEOUL, KOREA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647661 MI-1000 SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061525 00816835020171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown