BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3893945 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01408
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE INSPIRATORY MODULE PRINTED CIRCUIT BOARD (PCB), THE OXYGEN SENSOR AND THE OXYGEN SENSOR CABLE. THE CSE PERFORMED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE, THE 840 VENTILATOR OXYGEN SENSOR ALARMED, AND THE PT WAS PLACED ON ANOTHER UNIT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346201 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention