BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXLAB

    MDR report key: 9731889 · Received February 20, 2020

    Report

    Report Number
    3010825766-2020-00002
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 20, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172340004
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE FOLLOWED TO INSTALL THE HARDWARE KIT INDICATES FIRST OF ALL TO "CUT OFF ENERGY SUPPLIES". THE FSE ASKED BY EMAIL THAT THE LABORATORY ELECTRICAL POWER SUPPLY WAS OFF, BUT THE MAIN ELECTRICAL PANEL WAS STILL CONNECTED TO POWER. THE FSE DID NOT CHECKED THAT THE CIRCUIT WAS DEAD BEFORE STARTING THE REPLACEMENT AND DID NOT CUT OFF THE AUTOMATION SYSTEM POWER SUPPLY AS RECOMMENDED IN THE PROCEDURE. THE EVENT WAS CAUSED BY THE FSE ERROR. THE HARDWARE KIT AND THE INSTALLATION PROCEDURE WERE REVIEWED AND THERE IS NO NEED OF CHANGES. THE AUTOMATION SYSTEM IS PERFORMING AS EXPECTED. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AN INPECO FSE RECEIVED AN ELECTRICAL SHOCK WHILE HE WAS WORKING ON THE AUTOMATION SYSTEM, SPECIFICALLY HIS RIGHT HAND TOUCHED A LIVE 240V WIRE WHILE HE WAS REPLACING THE CIRCUIT BREAKER OF A DISTRIBUTION BOARD OF THE HIGH VOLUME STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196815 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA FLX 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1