BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL PATIENT CIRCUIT

    MDR report key: 3204029 · Received June 27, 2013

    Report

    Report Number
    MW5030733
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BUNNELL INC
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WATER LEVEL IN HUMIDIFIER CARTRIDGE OF CIRCUIT EXCEEDED OPERATING LEVEL ALLOWING WATER TO BE PUMPED INTO PT CIRCUIT. CARTRIDGE DEFECTIVE. SCRATCHES FOUND ON CIRCUIT CARD OF CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293104 BUNNELL PATIENT CIRCUIT PATIENT CIRCUIT FOR LIFE PULSE HIGH FREQUENCY LSZ BUNNELL INC PATIENT CIRCUIT 13025339

    Patients

    Seq Age Sex Outcome Treatment
    1 27 DA Life Threatening