BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4041055 · Received August 12, 2014

    Report

    Report Number
    8020893-2014-02026
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE RECOMMENDED TO RUN THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND TO RUN THE UNIT OVER THE WEEKEND. THE CUSTOMER REPORTED TO HAVE FOLLOWED THE TSE RECOMMENDATIONS AND HE WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN REC'D INFO STATING THAT AN 840 VENTILATOR STOPPED CYCLING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479204 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1