BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3880780 · Received April 9, 2014

    Report

    Report Number
    8020893-2014-00844
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE TOUCH-FRAME PRINTED CIRCUIT BOARD (PCB). THE DEVICE PASSED EXTENDED SELF-TESTING ACCORDING TO MANUFACTURER SPECIFICATIONS. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR EXPERIENCED A TOUCH SCREEN BLOCKED DEVICE ALERT. THE DEVICE WAS NOT BEING USED ON A PT WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214295 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1