BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3130404 · Received May 14, 2013

    Report

    Report Number
    3130404
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 14, 2013
    Manufacturer
    *
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OXYGEN SENSOR ALARM ON VENTILATOR ACTIVATED WITH CHANGE OR DISABLE MESSAGE. STAFF WAS PRESENT AT THE TIME AND PROPERLY VENTILATED THE PATIENT MANUALLY UNTIL VENTILATOR EXCHANGE WAS DONE AND BIO-MED NOTIFIED.======================MANUFACTURER RESPONSE FOR VENTILATOR, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================OUR OWN BIO MED STAFF SERVICES THE EQUIPMENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MECHANICAL VENTILATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214116 * VENTILATOR CBK * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR