Posts tagged defective medical devices

• Adverse Event Report on Defibrillators

  Staff Writer | June 16, 2006 3:51 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators because of an intermittent electrical connection that could result in failure, delay in analyzing the patient's ECG or failure to deliver expected therapy and resuscitation of the patient. A Class 1 recall occurs when there is reasonable probability that use...

• Guidant Defibrillators

  Staff Writer | May 21, 2006 1:57 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Many of you have learned of recent problems associated with implantable cardiac devices. Guidant Corporation's implantable defibrillator has been associated with potentially fatal complications. As a result of negative publicity, Guidant created a panel to investigate complaints. The May 18 edition of the New England Journal of Medicine contains an early release of their findings. Of note,...

• FDA Warns of Burns/Explosions From Oxygen Cylinders

  Staff Writer | April 25, 2006 7:06 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  The FDA and the National Institute for Occupational Safety and Health (NIOSH)issued a safety alert April 24, 2006, warning that 12 incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Improper use of gaskets/washersin the regulators are a major factor in the ignition and severity of the fires, and FDA and NIOSH...

• Depression Device

  Staff Writer | April 17, 2006 9:25 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  A Senate Finance Committee found that a top FDA official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, according to an article in the New York Times. The device has been used since 1997 to treat epilepsy, and when patients began reporting improvements in mood, the manufacturer sought approval...

• Dogs smell cancer

  Staff Writer | April 15, 2006 9:17 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  As if we needed convincing, here's more proof that dogs really can be man's (and woman's) best friend. An article in HealthDay News reports a new study showing that dogs can detect lung and breast cancer in breath samples.Here's an excerpt:"When we heard anecdotally that there was a device out there that might be able to detect cancer at its earliest stages, before it even shows up on an MRI...

• Strengthening Medical Device Safety

  Staff Writer | February 14, 2006 1:37 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  FDA has announced a new program that is designed to transform and strengthen medical device safety.This initiative will work toward an electronic reporting system and is expected to provide unique ways to identify medical devices including standardized and globally accepted names. Information in patient records about device information will be improved as will collaboration on post market...

• Guidant gives green light to Boston Scientific Offer

  Staff Writer | February 06, 2006 6:20 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Guidant Corp. has accepted Boston Scientific's acquisition offer of about $27 billion in cash and stock. Boston Scientific had been vying with Johnson and Johnson for a chance to acquire Guidant and gain entry into the fast-growing $10.3 billion cardiac-rhythm management market. Boston Scientific's enthusiasm for the merger was not dampened by Guidant's 1-23-06 announcement that it was...

• FDA Announces New Program to Transform and Strengthen Medical Device Safety

  Staff Writer | January 30, 2006 7:30 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  In the wake of the recent and too-numerous-to-count recalls of medical devices, the FDA announced on January 20, 2006 that it is launching a new program to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market -- both new technology and existing products.The FDA Center for Devices and Radiological Health's (CDRH) Postmarket...

• Proposed Roof Safety Standards Inadequate

  Staff Writer | January 06, 2006 10:40 AM | 0 CommentsColorado Springs, CO Category: Medical Malpractice
  

  According to the consumer watchdog group Public Citizen, the reently proposed changes to vehicle roof-crush standards are a joke, with 70% of current vehicles already meeting them.In their press release, Public Citizen notes:Rollover crashes kill 10,000 people each year, accounting for one-third of all occupant deaths in vehicle crashes. Many deaths and injuries that stem from rollover crashes...