BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2850463 · Received November 26, 2012

    Report

    Report Number
    8020893-2012-01268
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC SCREEN. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND RESEATED THE COLOR I/O PCB. NO PARTS WERE REPLACED. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1