BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION LIGHT

    MDR report key: 9271780 · Received November 4, 2019

    Report

    Report Number
    2028295-2019-00003
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 1, 2019
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FTD
    PMA / PMN Number
    K930897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARM SUPPORT FITTING SPECIFIED IN CUSTOMER COMPLAINT (B)(4) WAS RECEIVED IN TO ENGINEERING FOR FAILURE ANALYSIS. THE COMPONENT IS ON A DUAL CENTURION - CEILING MOUNT MODEL (021515 / S/N (B)(4)). THE COMPONENT WAS VISUALLY INSPECTED AND FOUND TO HAVE FAILED ON THE 1002036 UPPER TANG. THE WEAR-AND-TEAR OF THE UNIT WAS DEEMED VERY HIGH BECAUSE OF ITS AGE AND THERE WERE ALSO INDICATIONS THAT THE COMPONENT COULD HAVE EXCEEDED ITS LOAD LIMITS. WE REVIEWED THE MANUFACTURING DATE OF THIS UNIT AND FOUND ON SIMILAR INSTANCES OF THIS TYPE OF FAILURE FROM THIS DATE CODE. WE DID MULTIPLE CROSS-SECTION CUTS AND CAN RULE OUT POROSITY AS A POSSIBLE CAUSE OF FAILURE. HOWEVER THERE APPEARED TO BE STRESS-RELATED FACTORS AT THE BREAKING POINT. THESE INCLUDED A SLIGHT STRETCHING OF THE ALUMINUM TANG WHICH INDICATES THAT EITHER THE ARM WAS OVERLY STRESSED BY WEIGHT OR THE TORQUE ON THE COMPONENT MOUNTING BOLT. BOTH CONDITIONS WOULD GIVE THE SAME INDICATION AT THE BREAKING POINT OF THE 1002036. WE ARE ATTRIBUTING THE ULTIMATE CAUSE OF THIS FAILURE OF THE 1002036 AS BEING OVERSTRESSED. WE SPECULATE THAT THIS LIGHT EITHER HAD AN EXCESSIVE LOAD APPLIED ON THE ARM OR THAT THE MOUNTING BOLT WAS OVER-TIGHTEN TO REMOVE DRIFT IN THE SYSTEM. THIS IS DERIVED FROM THE FACT THAT THE TANG HAD SIGNS OF SLIGHT STRETCHING AT THE BREAK LINE WHICH IS INDICATIVE OF A STRESS FAILURE OR AN OVER CLENCHED BOLT.

    Description of Event or Problem · 1

    ON OCTOBER 7TH, AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION ABOUT A BROKEN ARM SUPPORT FITTING ON A CENTURION LIGHT SYSTEM. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069859 CENTURION LIGHT SURGICAL LIGHT FTD MEDICAL ILLUMINATION INTRNATION INC. 021515

    Patients

    Seq Age Sex Outcome Treatment
    1