BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3820094 · Received May 8, 2014

    Report

    Report Number
    8020893-2014-01122
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    COVIDIEN, FORMERY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS REPORT IS ON-GOING. AS ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(4) STATED AN 840 VENTILATOR'S TUBING WAS DISCONNECTED FROM A PATIENT'S NASOGASTRIC (NG) TUBE FOR REPOSITIONING OF THE NG TUBE. UPON RECONNECTING THE VENTILATOR TUBING TO THE NG TUBE, IT WAS NOTICED THAT THE VENTILATOR DID NOT RESUME VENTILATION. IT WAS REPORTED THAT THE SCREEN WAS LOCKED AND THE VENTILATOR DISPLAYED "CONNECT PATIENT". THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. DURING A FOLLOW-UP WITH THE USER FACILITY, IT WAS FOUND THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279654 840 VENTILATOR CBK COVIDIEN, FORMERY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention