Medical Malpractice

• How safe are you in the hospital?

  Jamie Sheller | February 20, 2008 3:13 PM | 0 CommentsPhiladelphia, PA

  Is it safer to be in the hospital during the day when having a heart attack than in the evening? According to recent research, a higher percentage of heart attack patients get better care during the day at a hospital, than between the hours of 11 pm and 6 am. Apparently, hospitals are better staffed and more attentive to patient needs during the day. Sadly, those who rely upon the staff the...

• Kidney Disease Associated With Gadolinium-Based Contrast Agent

  Jamie Sheller | December 26, 2006 10:27 AM | 0 CommentsPhiladelphia, PA

  Recently, the FDA updated an earlier public health advisory concerning gadolinium-based contrast agents used with MRI and MR angiography procedures. There have been a number of reports of a new disease called nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NSD) occuring in patients with moderate to end-stage kidney disease. Some patients developed NSF/NSD after only one...

• Recall of External Defibrillator

  Jamie Sheller | June 19, 2006 9:46 AM | 0 CommentsPhiladelphia, PA

  MRL, a division of Welch Allyn, is recalling about 500 of its model AED20 automatic external defibrillators. A faulty electrical connection could cause the device to malfunction and fail to resuscitate patients. For all customers of the recalled defibrillators, MRL will pay the costs to ship and replace the defective component. The FDA has determined that this action is a Class I recall,...

• Bidding War for Guidant Heats Up

  Jamie Sheller | January 20, 2006 7:28 AM | 0 CommentsPhiladelphia, PA

  After Guidant Corporation appeared ready to give its full support to latest bid from Johnson and Johnson, Boston Scientific raised its bid for Guidant, with help from Abbott Laboratories. The new offer, at $80 a share, quickly got Guidant to switch its support from the Johnson and Johnson proposal to Boston Scientific. The two companies have recently been in a bidding war for Guidant, which...

• Thoratec Implantable Ventricular Assist Devices Recalled

  Jamie Sheller | November 20, 2007 2:40 PM | 0 CommentsPhiladelphia, PA

  Thoratec Corporation has recalled its Implantable Ventricular Assist Devices (IVAD) catalog number 10012-2555-001, serial numbers 488 or higher. The recalled devices were manufactured and distributed from October 1,2 004 through October 22, 2007. These IVAD's are used to help pump blood through the body of a person whose body is too weak to perform that function. The IVAD can be implanted or...

• More Recalls of Guidant Heart Devices

  Jamie Sheller | April 12, 2007 12:36 PM | 0 CommentsPhiladelphia, PA

  Due to a defect causing shortened battery life, Guidant has recalled several models of its implantable cardiac defibrillators (ICD's) and cardiac resynchronization therapy defibrillators (CRT-D's). The recall involves about 73,000 devices, which have faulty capacitors possibly leading to rapid battery depletion. The Guidant ICD's and CRT-D's included in this recall are the Contak Renewal 3 HE...

• Safety Concerns Reported for Coronary Stents

  Jamie Sheller | September 08, 2006 9:16 AM | 0 CommentsPhiladelphia, PA

  At a recent European medical meeting, there were several reports about stent safety. Among the safety concerns was information showing increased risk of blood clots with the use of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent. Boston Scientific and Johnson & Johnson are the two biggest stent makers. Stents are used to keep arteries open after blockages are cleared in...

• Recall of Another External Defibrillator

  Jamie Sheller | July 11, 2006 8:11 AM | 0 CommentsPhiladelphia, PA

  The FDA has issued a Class 1 recall of Welch Allyn PIC 50 Automated External Defibrillators, manufactured between March 2002 and October 2004. The device may delay or fail to resuscitate the patient. This failure is caused by an eletrical contact problem. During this failure, the device may display various error messages including the "Defib Comm" message.

• Manufacturing Deficiencies With Baxter's Infusion Pump

  Jamie Sheller | July 05, 2006 8:40 AM | 0 CommentsPhiladelphia, PA

  Baxter Healthcare Corp. (Baxter) has stopped production and distribution of its Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until manufacturing deficiencies are corrected. This action was announced by the FDA and was part of a consent decree signed by Baxter and its CEO and Corporate Vice President. Patients use infusion pumps to control delivery of...

• Safety Alert Issued For More Boston Scientific Heart Devices

  Jamie Sheller | June 27, 2006 8:27 AM | 0 CommentsPhiladelphia, PA

  Boston Scientific has announced a safety alert regarding some of its pacemakers and cardiac defibrillators. "The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, AND VITALITY 2 implantable cardioverter defibrillators." An identified issue with a low-voltage capacitor may cause loss of...