BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3851302 · Received May 23, 2014

    Report

    Report Number
    8020893-2014-01250
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED MALFUNCTION. NO PARTS WERE REPLACED. THE CSE PERFORMED ALL THE CALIBRATIONS, THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER IN THE USA STATING THAT DUE TO AN 840 VENTILATOR MALFUNCTION, THE PATIENT WAS PLACED ON A SECOND VENTILATOR. THE CUSTOMER REPORTED THAT THE VENTILATOR STOPPED CYCLING. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308633 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention