BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL FILL CHAMBER

    MDR report key: 2021660 · Received March 11, 2011

    Report

    Report Number
    MW5019787
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    January 15, 2011
    Report Date
    March 11, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NICU STAFF WAS USING AN OXYGEN BLENDER - F & P HHFNC SYSTEM- TO DELIVER HIGH FLOW, HUMIDIFIED OXYGEN TO AN INFANT. THE CIRCUIT TUBING -RT 132- THAT WAS BEING USED DID NOT INCLUDE A HIGH-PRESSURE POP-OFF VALVE. WHEN LAYING THE INFANT IN HER CRIB, THE OXYGEN TUBING BECAME KINKED THUS CREATING A HIGH PRESSURE SCENARIO. THIS CAUSED THE PLASTIC TOP OF THE MANUAL FILL CHAMBER -MR250- TO FRACTURE AND BLOW OFF. DATES OF USE: (B)(6) 2011. EVENT ABATED AFTER USE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL FILL CHAMBER MANUAL FILL CHAMBER BTT FISHER & PAYKEL HEALTHCARE MR250 090727

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Disability