BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3822823 · Received February 5, 2014

    Report

    Report Number
    8020893-2014-00282
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE ADVISED THE CUSTOMER TO SEND THE DEVICE EVENT LOGS FOR DIAGNOSES ASSISTANCE. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR FAILED WITH A DEVICE ALERT OF COMMUNICATION ERROR. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76335 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1