BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3210162 · Received July 3, 2013

    Report

    Report Number
    8020893-2013-01516
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN RESULT OF TESTING BUT NO RESPONSE RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A VENT INOP CONDITION. THERE WAS NO PATIENT INVOLVEMENT. COVIDIEN TROUBLESHOT THIS ISSUE WITH THE CUSTOMER AND SUGGESTED TO RUN THE DEVICE OVERNIGHT. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305847 840 VENTILATOR VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1