BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELION S EXAM LIGHT

    MDR report key: 3982779 · Received July 23, 2014

    Report

    Report Number
    1066635-2014-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 23, 2014
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNICK GMBH & CO. KG
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A HELION S EXAM LIGHT ARM SYSTEM BROKE AT THE MIDDLE JOINT. THE LIGHT SYSTEM DID NOT HIT ANYONE AND THERE WERE NO INJURIES REPORTED. THE LIGHT WAS BEING MOVED BY A NURSE WHEN IT BROKE. THIS ARM WAS UNDER RECALL AT THE TIME OF THE INCIDENT. THE RECALL WAS INITIATED BY THE MFR KLM BECAUSE THE ARM SYSTEM MFR (ONDAL) DETERMINED THAT FATIGUE FAILURES WERE POSSIBLE IN THE PLASTIC JOINT. THE FACILITY WAS WORKING WITH TRUMPF TO REPLACE THE RECALLED ARMS WITH REPLACEMENTS. THE ARM AND ALL OTHERS AT THIS FACILITY HAVE NOW BEEN REPLACED. WE NOTIFIED KLM THE MFR ON 07/01/2014. THEY RESPONDED THAT THIS EVENT WAS RELATED TO THE RECALLED ARM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432104 HELION S EXAM LIGHT EXAM LIGHT FTD KARL LEIBINGER MEDIZINTECHNICK GMBH & CO. KG 88-300-00-04

    Patients

    Seq Age Sex Outcome Treatment
    1