BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3955602 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01422
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND BLACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCBS). THE CSE PERFORMED ALL CALIBRATIONS, SHORT SELF TEST, EXTENDED SELF TEST, AND PERFORMANCE VERIFICATION TESTS. ALL TESTS PASS PER MANUFACTURER'S SPECIFICATION AT THE TIME OF SERVICE. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT AN 840 VENTILATOR HAD A BLANK SCREEN. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344557 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1