BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3181934 · Received June 17, 2013

    Report

    Report Number
    8020893-2013-01329
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 23, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN...
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC SCREEN. THERE WAS NO PT INVOLVEMENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION, THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHIC USER INTERFACE (GUI) CPU PCB. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273512 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN... 840

    Patients

    Seq Age Sex Outcome Treatment
    1