BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PULSE HFV PATIENT CIRCUIT

    MDR report key: 2440405 · Received January 31, 2012

    Report

    Report Number
    MW5024104
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 31, 2012
    Manufacturer
    BUNNELL INC.
    Product Code
    BZO
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JET VENTILATOR ALARMED "CIRCUIT FAULT." BUNNELL HOTLINE CONTACTED AND EFFORTS AT TROUBLE SHOOTING FAILED SO PLAN WAS TO CHANGE THE CIRCUIT. WATER HAD COLLECTED IN THE FAILED CIRCUIT AND PATIENT RECEIVED WATER DOWN ET TUBE. PATIENT EXPERIENCED BRADYCARDIA AND DESATURATION. BABY WAS STABILIZED AND PLACED BACK ON JET WITH NEW CIRCUIT. 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 7 DA Disability VENTILATOR