BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3872360 · Received April 18, 2014

    Report

    Report Number
    8020893-2014-00947
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUPPORT ENGINEER (CSE) RAN EXTENDED SELF-TESTING (EST) PRIOR TO SOFTWARE UPDATE. THE VENTILATOR PASSED CALIBRATIONS, SHORT SELF-TESTS (SST), EXTENDED SELF-TESTING (EST), AND ELECTRICAL SAFETY. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT FROM (B)(6) WAS RECEIVED STATING THAT DURING SOFTWARE INSTALLATION THE DEVICE HAD A VENTILATOR INOPERATIVE CONDITION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238530 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1