Events

Recall of Internal Battery for Puritan Bennett 700 Series Ventilator.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett 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
    30779
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-05
  • Event Initiated Date
    2004-12-16
  • Event Date Posted
    2005-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36592
  • 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, Continuous, Facility Use - Product Code CBK
  • Reason
    Wires on battery may loosen causing disconnection.
  • Action
    Letters will be Fedexed to customers which includes a simple test instruction that users can use to test the performance of the back up alarm.

Device

Internal Battery for Puritan Bennett 700 Series Ventilator.
  • Model / Serial
    All produced from 3/1/02 to 5/12/04
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Europe, Japan, Latin America and other portions of Asia.
  • Product Description
    Internal Battery for Puritan Bennett 700 Series Ventilator.
  • Manufacturer
    Nellcor Puritan Bennett Inc

Manufacturer

Nellcor Puritan Bennett Inc
  • Manufacturer Address
    Nellcor Puritan Bennett Inc, 2200 Faraday Ave, Carlsbad CA 92008-7208
  • Source
    USFDA