BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHTECH

    MDR report key: 769033 · Received October 11, 2006

    Report

    Report Number
    MW1040655
    Event Type
    Other
    Date Received
    October 11, 2006
    Report Date
    October 11, 2006
    Manufacturer
    BREATHTECH/VENTLABS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR OF THE NEONATE HYPERINFLATION SYSTEM HS4051, VENTLABS, CHANGED THE PRODUCT WITHOUT NOTIFICATION. WE HAD JUST CHANGED PRIMARY VENDORS TO CARDINAL HEALTH. THE PRODUCT WE WERE USING FROM VENTLABS, HS4051. THE PRODUCT FROM CARDINAL HEALTH IS MANUFACTURED BY VENTLABS-UNDER THE BREATHTECH NAME. THE CARDINAL PRODUCT HS34051 WAS IDENTIFIED AS IDENTICAL TO THE PRODUCT WE USED. WHEN THE HS34051 WAS DELIVERED, WE FOUND THAT IT WAS DIFFERENT, WITH A PLUG FOR THE SAFETY VALVE, WHEN HIGHER PRESSURES ARE NEEDED. WE HAD REC'D NO NOTIFICATION OF A CHANGE FROM THE MFR. THE CONCERN WITH THE PLUG IS THAT PEOPLE TEND TO PLUG HOLES, THE HOLE IS THE SAFETY VALVE. WHEN THE PLUG IS IN USE; A BABY, BEING ASSISTED WITH THEIR FIRST BREATHS, COULD BE GIVEN EXCESSIVE PRESSURE - CAUSING A PNEUMOTHORAX. WE HAVE SEEN THE SAFETY VALVE PLUGGED ON SEVERAL OCCASIONS, NO INJURIES HAVE OCCURRED TO OUR KNOWLEDGE. WE ARE NOW ORDERING THE PRODUCT WITHOUT THE PLUG.THE MFR OF THE NEONATE HYPERINFLATION SYSTEM HS4051, VENTLABS, CHANGED THE PRODUCT WITHOUT NOTIFICATION. WE HAD JUST CHANGED PRIMARY VENDORS TO CARDINAL HEALTH. THE PRODUCT WE WERE USING FROM VENTLABS, HS4051. THE PRODUCT FROM CARDINAL HEALTH IS MANUFACTURED BY VENTLABS ? UNDER THE BREATHTECH NAME. THE CARDINAL PRODUCT HS34051 WAS IDENTIFIED AS IDENTICAL TO THE PRODUCT WE USED. WHEN THE HS34051 WAS DELIVERED, WE FOUND THAT IT WAS DIFFERENT, WITH A PLUG FOR THE SAFETY VALVE, WHEN HIGHER PRESSURES ARE NEEDED. WE HAD REC?D NO NOTIFICATION OF A CHANGE FROM THE MFR. THE CONCERN WITH THE PLUG IS THAT PEOPLE TEND TO PLUG HOLES, THE HOLE IS THE SAFETY VALVE. WHEN THE PLUG IS IN USE; A BABY, BEING ASSISTED WITH THEIR FIRST BREATHS, COULD BE GIVEN EXCESSIVE PRESSURE ? CAUSING A PNEUMOTHORAX. WE HAVE SEEN THE SAFETY VALVE PLUGGED ON SEVERAL OCCASIONS, NO INJURIES HAVE OCCURRED TO OUR KNOWLEDGE. WE ARE NOW ORDERING THE PRODUCT WITHOUT THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHTECH RESUSCITATOR, NEONATE HYPERINFLATION SYSTEM BTM BREATHTECH/VENTLABS HS34051 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other