BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851805 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00889
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSTALLED REVISION AK SOFTWARE. THE VENTILATOR PASSED CALIBRATIONS. EXTENDED SELF-TESTING (EST), AND SHORT SELF-TESTS (SST). COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA INDICATING THAT THE DEVICE EXPERIENCED ERROR CODES. THE ERROR CODES INDICATE A VENTILATOR INOPERATIVE CONDITION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221237 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1