BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2915309 · Received January 9, 2013

    Report

    Report Number
    8020893-2013-00052
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COVIDIEN, FORMELRY NELLCO
    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

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR WAS INOPERABLE. THERE WAS NO PT INVOLVEMENT. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. TSE RECOMMENDED RUNNING VENTILATOR ON TEST LUNG. COVIDIEN NOT AUTHORIZED TO EVALUATE THE DEVICE. THE CUSTOMER REPORTED TO HAVE NOT DUPLICATED THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11539 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMELRY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1