BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2820323 · Received October 31, 2012

    Report

    Report Number
    8020893-2012-01115
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN ADDITIONAL INFORMATION BUT NO RESPONSE RECEIVED FROM THE CUSTOMER. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. PATIENT CONDITION IS UNKNOWN. COVIDIEN TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. COVIDIEN SUGGESTED THE ANALOG INTERFACE OR THE POWER SUPPLY BE REPLACED. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE, THEREFORE, THE ROOT CAUSE OF THE ALLEGED MALFUNCTION CANNOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1