BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3925688 · Received June 17, 2014

    Report

    Report Number
    8020893-2014-01446
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB), UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT DURING PATIENT USE, AN 840 VENTILATOR STOPPED CYCLING. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356472 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention