About UPI  |  UPI en Español   |   My Account
Free News Update:
United Press International - News. Analysis. Insight.™ - 100 Years of Journalistic Excellence
  • Home
  • Top News
  • Entertainment
  • Odd News
  • Sports
    • Baseball
    • Football
    • Golf
    • Olympics 2008
    • Tennis
  • Business
  • Science
  • Health
  • Analysis
    • Energy Resources
    • Security Industry
    • Emerging Threats
  • Media
    • Video
    • News Photos
  • Features
    • The Voice of Young Voters
    • Path to the Presidency
    • Energy
    • Beijing Olympics 2008
Search:
Go
You are here:  Home / Science News / Heart defibrillator company signs decree

Science News

View archive | RSS Feed

Heart defibrillator company signs decree

Published: May 1, 2008 at 12:48 PM
Order reprints  |  Print Story  |  Email to a Friend  |  Post a Comment
WASHINGTON, May 1 (UPI) -- The U.S. Food and Drug Administration said Medtronic Inc. (NYSE:MDT) has agreed to comply with FDA rules in manufacturing its external heart defibrillators.

The FDA said Medtronic, its Physio-Control Inc. subsidiary and two high-ranking executives signed a consent decree calling for a permanent injunction involving the company's automatic external defibrillators manufactured by Physio-Control.

"The consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance with the Food and Drug Administration's current 'Good Manufacturing Practice' requirements, as set forth in the … regulation for devices," the FDA said in a statement.

AEDs are portable devices used to restore normal heart rhythm to people who suffer heart attacks that produce ventricular fibrillation. The AEDs deliver an electric shock that stuns the heart for a moment, giving it the chance to resume beating effectively.

FDA inspections revealed deficiencies in the manufacturing process. Although those deficiencies don't necessarily mean that the defibrillators on the market will harm patients, the FDA said it is requiring corrections to "ensure the continued availability of safe, effective and reliable products."

RATE THIS ARTICLE
    Poor    1    2    3    4    5  Excellent    
Feedback


© 2008 United Press International, Inc. All Rights Reserved.
Have an opinion? Leave a comment. No Registration Required.
News Photos Slideshows
Photos of the Day
Week in Photos
News
Entertainment
Sports
Features
Archives
Olympics 2008
Path to the Presidency
Additional News Stories
Top News
  • Tropical Storm Nana likely shortlived
  • Stanford grieves grad students' deaths
  • Poll: Obama leads McCain 53-43
  • Momentum builds for Taliban negotiations
  • China to double farmers' per capita income
Science News
  • Some Russell Stover-brand candy recalled
  • No-Name-brand flour is recalled in Ontario
  • Rapaflo OK'd to treat enlarged prostate
  • Deep 6.2 quake rocks Bolivia
  • Astronaut's son follows him in space
Entertainment News
    Report: Lopez & Anthony renew their vows
    Report: Lopez & Anthony renew their vows
    LAS VEGAS, Oct. 13 (UPI) --
    Jennifer Lopez and Marc Anthony, who have been married for four years and are the parents of twins, reportedly renewed their wedding vows in Las Vegas Sunday.
  • Stars line up for casino opening
  • McCain set to appear on 'Letterman'
  • Everett to make Broadway debut
  • Pakistani movie actor Munir dead at 70
Health News
    Tina Fey's impersonations may have impact
    Tina Fey's impersonations may have impact
    WASHINGTON, Oct. 13 (UPI) --
    GOP vice presidential nominee Sarah Palin may make a cameo on NBC's "Saturday Night Live," but it may not help in the polls, a U.S. expert says.
  • Study: Multiracial people face prejudice
  • U.S. adults worry more about economy
  • Britain to ban free alcohol for women
  • Plastic surgery makes advances in wartime
UPI Features - The Voice of Young Voters
Most Popular
Stories
Photos
Videos
People
1.
Astronaut's son follows him in space
2.
Former head of MIT math department dies
3.
New Google Earth satellite image released
4.
Report: 1 in 4 mammals face extinction
5.
Space station crew might not be expanded



Explore
Volcanic Eruption in Chaiten
Volcanic Eruption in Chaiten
Images from the Hubble Telescope
Images from the Hubble Telescope
The Great White Shark
The Great White Shark
Nobel Prize in Physics Ceremony
Nobel Prize in Physics Ceremony
© 2008 United Press International, Inc. All Rights Reserved. Official Government Wires  |   About UPI  |   Site Map  |   Terms of Use  |   Privacy Policy  |   Advertise Online  |   Contact Us

Sponsored Links: Auto Dealers - College Football Tickets - Fundraisers - Press Release Services - prom dresses - Prom dresses and gowns - Public Records - Wedding and Honeymoon Experts - Motivational Sports Speakers Bureau