BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3001989 · Received March 11, 2013

    Report

    Report Number
    8020893-2013-00523
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE WAS NO PATIENT INVOLVEMENT. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER FOLLOWED THE TSE RECOMMENDATIONS AND UNIT PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102217 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1