BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3900422 · Received May 6, 2014

    Report

    Report Number
    8020893-2014-01073
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN SERVICE ENGINEER (CSE) HAS BEEN SCHEDULED TO REPAIR THIS DEVICE. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE USA STATING THAT AN 840 VENTILATOR EXPERIENCED A MALFUNCTION. IT WAS REPORTED THAT THE GRAPHIC USER INTERFACE (GUI) SCREENS WERE BLANK. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272021 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1