BEUDAMED
    FDA Adverse Event Summary report: N

    LIFE PULSE HFV PATIENT CIRCUIT

    MDR report key: 2440403 · Received January 31, 2012

    Report

    Report Number
    MW5024103
    Date Received
    January 31, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 31, 2012
    Manufacturer
    BUNNELL INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXCESS WATER COLLECTED IN THE CIRCUIT AND BEGAN TO FILL THE JET LIFEPORT ADAPTER. WATER CONTINUED TO COLLECT FOLLOWING SUCTIONING AND PATIENT BECAME BRADYCARDIC AND HAD DECREASED SPO2. BUNNELL HOTLINE CONTACTED. CIRCUIT CHANGED AND LOWERED CIRCUIT TEMPERATURE. PATIENT STABILIZED AND PLACED BACK ON JET WITH NEW CIRCUIT. NO INJURY TO PATIENT. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HFV PATIENT CIRCUIT CIRCUIT BZO BUNNELL INC. 11F192

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Disability VENTILATOR