BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962645 · Received June 18, 2014

    Report

    Report Number
    8020893-2014-01454
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE FOUND AN ERROR CODE RELEVANT TO THE MALFUNCTION RECORDED IN THE MEMORY LOGS, AND REPLACED THE GRAPHIC USER INTERFACE (GUI), CENTRAL PROCESSING UNIT (CPU), PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT DURING SET-UP OF AN 840 VENTILATOR, THE UNIT EXPERIENCED A DEVICE ALERT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356856 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1