BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3240272 · Received July 18, 2013

    Report

    Report Number
    8020893-2013-01623
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 18, 2013
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK DISPLAY WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE AND SUGGESTED TO CHANGE THE BATTERY RUN THE EXTENDED SELF-TEST (EST) AND RUN THE TEST LUNG. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334833 840 VENTILATOR VENTILATOR CBK COVIDIEN FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention