BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851787 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00888
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR EXPERIENCED DEVICE ALERTS RENDERING THE VENTILATOR INOPERABLE. 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
    221215 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1