Posts tagged Medical Devices

• Sleep Apnea Flow Generators Recalled

  Shannon Weidemann | April 30, 2007 10:45 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Some flow generators used in the treatment of sleep apnea have been recalled. ResMed is voluntarily recalling S8 flow generators made between July 2004 and May 15, 2006 because the power supply connector may short circuit. This creates a potential for machine failure, sparks and fire. Patients may continue to use their S8 flow generators until they receive a replacement device. As with any...

• Court Denies Medtronic's Motion for Summary Judgement

  Staff Writer | December 15, 2006 10:37 AM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  Defibrillator manufacturer Medtronic asked the US District Court of Minnesota to consider a motion for summary judgement. Their request was based on the claim that federal preemption barred the plaintiffs' claims. The plaintiffs' main complaint sites state law product liability claims sounding in negligence and strict liability. Other claims include violations of state Consumer Protection...

• Medtronic Fails to Warn Public of Malfunctioning Battery

  Staff Writer | December 15, 2006 10:30 AM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  According to Medtronic's website, "Medtronic is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world." Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D's) and implantable cardioverter-defibrillators (ICD's). These devices are used on patients with heart conditions and are surgically...

• Defibrillators and Pacemakers

  Staff Writer | October 02, 2006 8:51 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  On September 29, 2006, The Heart Rhythm Society (HRS) finalized recommendations for revising the system used by industry, regulators and clinicians to monitor and publicize implantable-device performance problems. Key goals of the recommendations include:• improved recognition of potential device malfunctions• postmarket surveillance and reporting of any problems• communication among...

• FDA Warning to Medtronic on Defibrillators

  Staff Writer | September 29, 2006 7:17 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use...

• Boston Scientific's Taxus Stent

  Staff Writer | September 07, 2006 11:10 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product; 200 Taxus stents were recalled earlier this month. In a meeting with the FDA in...

• FDA Announces Recall of Certain Welch Allyn Automated External Defibrillators

  Staff Writer | July 31, 2006 6:39 PM | 0 CommentsDenver, CO Category: Medical Malpractice
  

  The US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.The recall occured because of an electrical contact problem that...

• 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...