BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3881097 · Received April 7, 2014

    Report

    Report Number
    8020893-2014-00826
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED BY THE COVIDIEN CUSTOMER SVC ENGR (CSE). THE BACKLIGHT INVERTER BOARD WAS REPLACED. THE DEVICE PASSED ALL CALIBRATIONS, INCLUDING THE EXTENDED SELF TEST (EST), SHORT SELF-TEST (SST) AND ELECTRICAL SAFETY TESTING. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS AT THE TIME OF SVC. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA INDICATED AN 840 VENTILATOR WITH A GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) FAILURE. THERE WAS NO REPORTED PT INVOLVEMENT. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209761 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1