BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 2163099 · Received July 6, 2011

    Report

    Report Number
    2163099
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SMITHS MEDICAL PM
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PARAPAC VENTILATOR CIRCUIT WAS CONNECTED INCORRECTLY TO A PATIENT WITH AN ENDOTRACHEAL TUBE DURING TRANSPORT RESULTING IN THE PATIENT NOT BEING VENTILATED ADEQUATELY. THE EXHALATION VALVE WAS CONNECTED INCORRECTLY TO THE BALLARD CATHETER WHICH PREVENTED THE PATIENT FROM RECEIVING GAS SUPPLY FROM THE VENTILATOR. BECAUSE THE INLET AND OUTLET OF THE EXHALATION VALVE CAN CONNECT TO THE BALLARD CATHETER AS WELL AS THE VENTILATOR CIRCUIT, THIS LED TO THE INCORRECT APPLICATION.======================MANUFACTURER RESPONSE FOR VENTILATOR CIRCUITRY, PNEUPAC VENTILATOR CIRCUIT PN- 122003. (PER SITE REPORTER)======================NOTHING AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC SET, TUBING, PATIENT CIRCUIT BZO SMITHS MEDICAL PM 122003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR