BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3905676 · Received May 28, 2014

    Report

    Report Number
    8020893-2014-01295
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED EXTENDED SELF-TESTING. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE VENTILATOR INOPERABLE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315163 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1