BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2961114 · Received January 30, 2013

    Report

    Report Number
    8020893-2013-00243
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN IF THE ACTION RECOMMENDED BY COVIDIEN TSE RESOLVED THE ISSUE BUT NO RESPONSE RECEIVED FROM THE CUSTOMER. A FOLLOW UP REPORT WILL BE SUBMITTED IF AND WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE WAS NO PATIENT INVOLVEMENT. COVDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO RUN EXTENDED SELF TEST AND INSPECT THE INSPIRATORY MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40169 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1