BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853175 · Received April 3, 2014

    Report

    Report Number
    8020893-2014-00792
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) AND ANALOG INTERFACE (AI) CPU. THE CSE ALSO PERFORMED ELECTRICAL SAFETY, RAN ALL CALIBRATIONS, AND THE EXTENDED SELF-TEST (EST) AND SHORT SELF-TEST (SST). ALL TESTS PASSED PER MFR'S SPECIFICATIONS AT THE TIME OF SERVICE. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 EXPERIENCED AN ERROR CODE THAT RENDERED THE VENTILATOR INOPERABLE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203022 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1