BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3935565 · Received June 23, 2014

    Report

    Report Number
    8020893-2014-01475
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW UP WITH THE USER FACILITY, THE COVIDIEN CLINICAL SPECIALIST CONFIRMED THE REPORTED EVENT RESULTED FROM A CLINICAL USE ERROR. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE TO THE MANUFACTURER. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A LOW PRESSURE ALARM. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364596 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention