BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORLOCATE

    MDR report key: 6954785 · Received October 17, 2017

    Report

    Report Number
    6954785
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 19, 2017
    Report Date
    September 29, 2017
    Manufacturer
    HALDOR USA INC.
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SETUP AND CONFIGURATION OF ORLOCATE IT WAS DISCOVERED THAT THEY HAVE TWO WIRELESS NETWORKS. ONE CONNECTS TO THE HOSPITAL IT WIRELESS NETWORK AND THE OTHER CONNECTS TO PIECES OF ORLOCATE EQUIPMENT. THE HOSPITAL HAD A WIRELESS SECURITY PRODUCT IN PLACE TO PREVENT UNAUTHORIZED WIRELESS NETWORKS WITHIN THE HOSPITAL PERIMETER. THE SECURITY PRODUCT DISRUPTED ORLOCATE'S "INTERNAL" WIRELESS NETWORK AND MADE THE WIRELESS NETWORK CONNECTIVITY APPEAR SPORADIC AND UNRELIABLE. THE VENDOR WAS UNAWARE OF THIS TYPE OF WIRELESS SECURITY AND IT DIDN'T OCCUR TO LET THE IT DEPARTMENT STAFF KNOW THAT IT WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736234 ORLOCATE COUNTER, SPONGE, SURGICAL LWH HALDOR USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1