Events

Recall of Device Recall Life Pulse High Frequency Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bunnell, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63710
  • Event Risk Class
    Class 1
  • Event Number
    Z-0514-2013
  • Event Initiated Date
    2012-11-19
  • Event Date Posted
    2012-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114595
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, high frequency - Product Code LSZ
  • Reason
    Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. bunnell is recalling all lots of circuits distributed between march 12, 2012 and november 30, 2012.
  • Action
    On 12/5/12, the firm, Brunnell, Inc., issued a public press notification to their consignees. A. On or before 12-12-2012 a certified letter will be sent to all customer listed in the customer database. Specifically each customer will receive two certified letters; one directed to Director of Respiratory Therapy and a second to the Director of Biomedical Engineering. The certified letter will contain a copy of the Recall Noticeand a copy of the Certificate of Medical Necessity. The Certified Letter receipts will be maintained. On the mailing date a copy of the Recall Notice will be placed on the Bunnell website. B. An Excel database will be maintained for each customer/lot #. The database will contain the current status for each. Included will be: 1. Customer Information 2. Date Certified Letter Sent 3. Date receipt received and filed 4. Date product returned or that no stock remains 5. Lot number & Quantity C. On or before 02-01-2013, a second letter will be sent to those customers who have not responded to the original certified letter. D. Data will be maintained in the database E. On or before 04-01-2013, a phone call will be placed to those customers who have not responded to either of the letters. F. Data will be maintained in the database G. On or before 04-15-2013, a second phone call will be placed to those customers who have not responded to the letters or previous phone call. H. Data will be maintained in the database I. On or before 06-07-2013, a Final Recall Notification certified letter will be sent to those customers who have not responded to either of the previous letters or phone calls. J. The Certified Letter receipt will be maintained K. Data will be maintained in the database L. When PMA for alternate heater wire is approved, steps A-K will be repeated. Dates will be determined. M. Following completion of Step L, a final review of the database will occur. Final tabulation of the status for each custo

Device

Device Recall Life Pulse High Frequency Ventilator
  • Model / Serial
    Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot # on the label on outside of box: 12C099, 12C114, 12C124, 12C135, 12D152, 12D170, 12D188, 12E203, 12E210, 12E223, 12F238, 12F255, 12F274, 12G209, 12G280, 12H334, 12H341, 12I356, 12I369, 12I392, 12J411, 12J425, 12J447, 12K467, 12K479
  • Product Classification
    Anesthesiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
  • Product Description
    Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. || Model #(s): || Individual Patient Circuit - catalog # 902 || Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. || Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. || Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
  • Manufacturer
    Bunnell, Inc.

Manufacturer

Bunnell, Inc.
  • Manufacturer Address
    Bunnell, Inc., 436 Lawndale Dr, Salt Lake City UT 84115-2917
  • Source
    USFDA