BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3897164 · Received May 21, 2014

    Report

    Report Number
    8020893-2014-01209
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 22, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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) PRINTED CIRCUIT BOARD (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION AND PERFORMED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT WHILE IN USE ON A PATIENT AN 840 VENTILATOR GENERATED AN ERROR MESSAGE THAT RENDERED IT INTO AN INOPERABLE STATE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303940 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1