BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 8609917 · Received May 14, 2019

    Report

    Report Number
    2028295-2018-00004
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    January 12, 2018
    Report Date
    February 5, 2018
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT FROM CUSTOMER COMPLAINT # (B)(4) WAS RECEIVED AND AN INVESTIGATION WAS INITIATED. THE DOUBLE CEILING MOUNTS P/N 1002060 ARE TWO PARTS CLAMPED TOGETHER. THE FIRST HALF HAD NO BREAKS. TH SECOND HALF HAD BREAKS IN TWO PLACES. VISUAL INSPECTION OF THE BROKEN PARTS WITH THE AID OF MAGNIFICATION NO POROSITY OR VOIDS WERE PRESENT. ONE OF THE ABASHING S/A/S, P/N 1000234, HAD THE FIRST TWO THREADS STRIPPED OUT, MINIMIZING THREAD ENGAGEMENT AND REDUCING THE CLAMPING FORCE BY THAT ONE SCREW LOCATION, WHICH MAY HAVE CAUSED SOME WEAKNESS IN THE TOTAL CLAMPING FORCE. WHEN WE WENT TO THE FACILITY, ONLY 2 SCREWS WERE PRESENT IN THE MOUNTING ASSEMBLY. THE FACILITY STAFF DID NOT KNOW IF ALL THE SCREWS WERE INSTALLED WHEN THE P/N 1002060 PART BROKE, BUT THESE SCREWS WERE NOT PRESENT UPON OUR ARRIVAL. IT IS SUSPECTED THAT THE SCREWS USED TO SECURE BOTH HALVES TOGETHER (SCREWS P/N 0001291, 8 PLACES) WERE NOT SUFFICIENTLY TIGHTENED, OR MISSING CAUSING THE COMBINED LACK OF STRENGTH REQUIRED TO MAINTAIN THE STRUCTURAL INTEGRITY OF THE CLAMPING FORCE FOR THE ENTIRE MOUNTED ASSEMBLY. THE ONE STRIPPED OUT THREAD LOCATION IN THE P/N 10000234 BUSHING S/A MAY HAVE CAUSED SOME WEAKNESS, IF THE SCREW WAS NOT PRESENT OR WAS NOT ENGAGED. WE WERE NOT ABLE TO DETERMINE IF THE 2 SCREWS WERE INSTALLED CORRECTLY ON THE OTHER SIDE OF THE ASSEMBLY. ALL 8 SCREWS MUST BE INSTALLED PER THE INSTRUCTIONS FOR USE MANUAL TO INSURE ADEQUATE SYSTEM STRENGTH. THE COMBINED STRESS ON THE P/N 1002060 CASTING WITH ONLY 2 SCREWS INSTALLED WOULD BE HIGH AND COULD CAUSE PART TO FAIL. IT IS OUR ASSUMPTION THAT THE MISSING SCREWS CAUSED THE FAILURE. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMRD INSTEAD OF PRODUCTION. [(B)(4)].

    Description of Event or Problem · 1

    ON (B)(6) 2018 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING A DUAL CEILING MOUNT MI-1000 WHERE ONE HALF OF THE CEILING MOUNT CASTING BROKE, CAUSING ONE OF THE TWO LIGHTS ON THE MOUNT TO FALL. THE (B)(4) STATED THERE WERE MINOR INJURIES SUSTAINED WHEN THE CHARGE NURSE TRIED TO CATCH THE LIGHT, STRAINING HER ARM, AND STRIKING THE DR. IN THE HEAD (SLIGHT HEADACHE). IT WAS ALSO SAID THAT THE PATIENT WAS GRAZED ON THE LEFT SHOULDER CAUSING A SMALL TEAR IN HIS SHIRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400048 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061515

    Patients

    Seq Age Sex Outcome Treatment
    1