BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2152369 · Received June 24, 2011

    Report

    Report Number
    8020893-2011-00278
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT WAS TURNED OFF WHILE ON A DNR PATIENT THEN TURN BACK ON LATER WITH NO BAD EFFECTS TO THE PATIENT. CUSTOMER REPORTED THAT THIS WAS A TRAINING ISSUE AND THEY HAVE PUT TOGETHER A PROCESS WHICH COULD NOT BE SHARED WITH COVIDIEN. CUSTOMER REPORTED NO VENTILATOR PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1