BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3983159 · Received July 3, 2014

    Report

    Report Number
    8020893-2014-01562
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE USER FACILITY WAS ADVISED TO REPLACE THE BREATH DELIVERY (BD), PRINTED CIRCUIT BOARD (PCB). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS DISPATCHED, AND THE CSE DOWNLOADED THE CURRENT SOFTWARE ONTO THE CUSTOMER PURCHASED BD PCB. THE VENTILATOR PASSES TESTING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO OF VENTILATOR BECOMING INOPERABLE. THE MALFUNCTION DID NOT OCCUR DURING PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392348 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1