BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922106 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01324
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) EVALUATED THE 840 VENTILATOR, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB), AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. ALL REQUIRED CALIBRATIONS AND TESTS WERE PERFORMED, 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 INOPERATIVE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321813 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1