BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3894144 · Received February 6, 2014

    Report

    Report Number
    8020893-2014-00317
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THAT THE CUSTOMER REPLACED THE BDU PCB. THE CSE UPGRADED THE SOFTWARE AND THE VENTILATOR PASSED THE TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE VENTILATOR SHUT DOWN. THE CUSTOMER REPORTED TO HAVE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78825 840 VENTILATOR CBK; VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1