BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 774988 · Received October 27, 2006

    Report

    Report Number
    MW1040830
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 27, 2006
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT: SALTER LABS FULL KIT NEBULIZER SET. EVENT: THE NEBULIZER WITH OXYGEN TUBING ATTACHED WAS CONNECTED DIRECTLY TO THE ENDOTRACHEAL TUBE VIA THE ETT CONNECTOR IN A PT WHO HAD PREVIOUSLY BEEN BREATHING VIA A T-PIECE. THE NURSE TENDING THE PT THEN RECOGNIZED THE PROBLEM AND IMMEDIATELY DISCONNECTED THE NEBULIZER. THE PT DID NOT REQUIRE FURTHER INTERVENTION RELATED TO THIS ISSUE. THE NEBULIZER IS DESIGNED TO BE ATTACHED, VIA ITS 17 MM OUTSIDE DIAMETER CONNECTOR, TO THE T-PIECE PROVIDED IN THE KIT. HOWEVER, THE NEBULIZER CONNECTOR HAS AN INTERNAL DIAMETER OF 15 MM WHICH PERMITS DIRECT ATTACHMENT TO AN ORDINARY ENCOTRACHEAL TUBE CONNECTOR. WE BELIEVE THIS IS A DESIGN FLAW THAT PERMITS AN ERROR THAT COULD HAVE SERIOUS PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS FULL KIT NEBULIZER SET CAF SALTER LABS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening