BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3902545 · Received May 8, 2014

    Report

    Report Number
    8020893-2014-01131
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) COMMUNICATIONS FLEX CIRCUIT CABLE, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. VENTILATOR PASSED CALIBRATIONS AND EXTENDED SELF-TESTING (EST). (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT THE TOP PORTION OF AN 840 VENTILATOR WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279939 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1