BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8609589 · Received May 14, 2019

    Report

    Report Number
    2028295-2018-00002
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    November 30, 2017
    Report Date
    January 25, 2018
    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 LISTED UNDER CUSTOMER COMPLAINT #(B)(4) AND IMITATED AN INVESTIGATION. THE PRODUCT WAS A MI-1000 SINGLE CEILING MOUNT. A VISUAL INSPECTION WAS PERFORMED AND OTHER THAN THE ARM SUPPORT FITTING (P/N 1002036) THERE WAS LIGHT SURFACE DAMAGE FOUND (IE: NICKS AND SCRATCHES). BECAUSE THE ARM SUPPORT FITTING (1002036) WAS TESTED SEVERAL WEEKS AGO UNDER RMA # (B)(4) FOR ANOTHER CUSTOMER COMPLAINT (#(B)(4)). THE LOAD TEST WAS NOT RUN AGAIN. WE DID CROSS-SECTION ANALYSIS ON THE FAILED SURFACES AND DID NOT SEE ANY POROSITY OR ABNORMAL MATERIAL FLOW PATTERNS. WE COULD NOT DEFINITIVELY DETERMINE THE CAUSE OF THE FAILURE. THE LIGHT SURFACE DAMAGE WAS DEEMED INCONSEQUENTIAL. THIS ARE WAS OUT OF (B)(4) SOLD IN 2014 AND THIS IS THE ONLY FAILURE OF THIS COMPONENT REPORTED FOR THAT PRODUCTION YEAR. 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 FRACTURING CAUSING THE LIGHT TO FALL. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402724 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061514-V

    Patients

    Seq Age Sex Outcome Treatment
    1