BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX

    MDR report key: 3113349 · Received May 2, 2013

    Report

    Report Number
    3113349
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    NELLCOR PURITAN BENNETT, INC
    Product Code
    MUD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO PATIENT WAS DIRECTLY INVOLVED WITH THIS INCIDENT. SATURATION (SAT) PROBE WAS PULLED FROM CR (CARDIORESPIRATORY) MONITOR IN PATIENT ROOM AND A PIECE OF THE PLASTIC BROKE OFF AND IS STUCK INSIDE OF THE MONITOR. A NEW SAT PROBE CORD WAS TAKEN FROM THE PATIENT ROOM AND THAT CORD ALSO BROKE OFF AND A PIECE WAS LEFT BEHIND IN CR MONITOR. CLINICAL ENGINEERING WORK ORDERS WERE PLACED AND SUPERVISOR WAS NOTIFIED. BIO ENGINEERING STATED THAT THIS IS A FREQUENT OCCURRENCE AND THIS IS A FREQUENT REPAIR. IF THE CABLE IS NOT PULLED OUT IN A STRAIGHT LINE, THE CONNECTOR COVER BREAKS OFF AND A PART STAYS IN THE MACHINE AND WILL NOT ALLOW ANOTHER CABLE TO BE PLUGGED IN. INCIDENTS MAY BE OCCURRING BECAUSE OF USE ERROR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193592 OXIMAX OXIMETER, TISSUE SATURATION MUD NELLCOR PURITAN BENNETT, INC 3761000 *
    193593 OXIMAX OXIMETER, TISSUE SATURATION MUD NELLCOR PURITAN BENNETT, INC 3761200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *