BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOPROCESSOR

    MDR report key: 6089846 · Received November 9, 2016

    Report

    Report Number
    6089846
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    March 30, 2016
    Report Date
    September 30, 2016
    Manufacturer
    HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEDICS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPY AND ORIF ORTHOPEDIC PROCEDURE, THE COMPUTER ON THE TOWER (WHERE YOU CAN ENTER THE PATIENT'S INFORMATION AND WHERE IT HAS THE CONTROL RECORDINGS) TURNED OFF SPONTANEOUSLY. IT HAD TO BE RESET AND TURNED BACK ON. WHEN IT WAS RESET, THE PATIENT'S DATA WAS MISSING FROM THE SYSTEM. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739859 VIDEOPROCESSOR SYSTEM, IMAGE PROCESSING LLZ HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEDICS SK18-SYSA0936025

    Patients

    Seq Age Sex Outcome Treatment
    1