BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2982783 · Received February 25, 2013

    Report

    Report Number
    8020893-2013-00441
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE F/U CALLS WERE MADE TO OBTAIN RESULT OF TESTING BUT NO RESPONSE RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE WAS NO PT INVOLVEMENT. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE AND SUGGESTED TO REPLACE THE BREATH DELIVERY UNIT (BDU) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79116 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1