BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3851126 · Received May 22, 2014

    Report

    Report Number
    8020893-2014-01239
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND ISOLATED THE MALFUNCTION TO THE TOUCHSCREEN PRINTED CIRCUIT BOARD (PCB). THE CSE REPLACED THE TOUCHSCREEN PCB. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM PORTUGAL STATING THAT, DURING PATIENT USE, AN 840 VENTILATOR HAD A FAULTY DISPLAY. THE DISPLAY WAS FOUND TO BE UNRESPONSIVE. THE VENTILATOR CONTINUED TO CYCLE. THE PATIENT WAS REMOVED FORM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306662 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention