BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4101871 · Received August 25, 2014

    Report

    Report Number
    8020893-2014-02077
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Removal / Correction Number
    Z-1809-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND PERFORMED THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTS AND OPERATES WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT AN 840 VENTILATOR HAD A BLANK DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510951 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1