BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922095 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01335
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB), AND UPDATED THE SOFTWARE. THE VENTILATOR PASSED EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST), AND PERFORMANCE VERIFICATION TESTING (PVT). IT WAS CALIBRATED, AND THE UNIT WAS OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR STOPPED CYCLING, AND BECAME INOPERABLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321876 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1