BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGENT CIRCUIT KIT

    MDR report key: 887786 · Received June 29, 2007

    Report

    Report Number
    887786
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    June 14, 2007
    Report Date
    June 20, 2007
    Manufacturer
    PLASTICS ENGINEERING AND DEVELOPMENT, INC. (PEDI)
    Product Code
    NHJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN RESPIRATORY DISTRESS. STAFF PLACED THE CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MASK ON THE PATIENT. THERE WAS GOOD AIR FLOW, BUT NO PRESSURE WAS PRESENT TO PUSH AIR INTO THE LUNGS. THE FAILURE OF THE CIRCUIT CAUSED A DELAY IN TREATMENT. WHEN ANOTHER CIRCUIT WAS USED, THE SITUATION IMPROVED. NO FURTHER COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGENT CIRCUIT KIT TUBING, CPAP NHJ PLASTICS ENGINEERING AND DEVELOPMENT, INC. (PEDI) * ERP124-1M/030306

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R