BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3873752 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00878
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COVIDIEN, FOREMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE POWER SWITCH. THE UNIT PASSED ALL TESTS. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFORMATION STATING THAT AN 840 VENTILATOR SHUT DOWN AND DISPLAYED AN INOPERATIVE BATTERY ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221290 840 VENTILATOR CBK COVIDIEN, FOREMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1