Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Cardiac Science AEDs: Cardiac Science initiated a field correction Nov. 13 on several models of its Powerheart and CardioVive automated external defibrillator devices that may not delivery therapy during a resuscitation attempt. AED display screens and audible indicators may not accurately indicate whether the device is functioning properly, FDA notes in a Nov. 19 safety communication. About 300,000 devices are potentially affected, and a software correction will not be available until May 2010. Cardiac Science recommends customers leave their AEDs in service, but FDA urges users to seek alternative products, if possible. The company stopped production on some Powerheart AEDs in late June after discovering a resistor malfunction, but resumed shipments Aug. 10. AEDs produced since August are unaffected, the firm stresses. The company earlier predicted that the quality issues could cost upwards of $20 million to resolve (1"The Gray Sheet" Aug. 17, 2009)

You may also be interested in...



Cardiac Science To Replace 24,000 AEDs, Adding Millions To Recall Cost

Cardiac Science will replace about 24,000 automated external defibrillators (AEDs) used by first responders and certain medical facilities under an updated recall plan that could end up costing the firm $33.5 million

Cardiac Science To Replace 24,000 AEDs, Adding Millions To Recall Cost

Cardiac Science will replace about 24,000 automated external defibrillators (AEDs) used by first responders and certain medical facilities under an updated recall plan that could end up costing the firm $33.5 million

Regulatory News In Brief

FDA stent guidance: Agency releases 1guidance April 30 on non-clinical engineering tests and recommended labeling for intravascular stents and stent delivery systems. The document suggests what test data should be included and how data should be formatted. For example, the guidance makes testing recommendations regarding material composition, fatigue/durability, MRI safety and compatibility, crush and kink resistance, shelf-life and biocompatibility. The guidance covers self-expanding and balloon expandable stents used in coronary and peripheral arteries, as well as stents for other vascular indications; non-vascular stents and stents used in the intracranial vasculature are outside the scope of the guidance. Some of the recommendations are relevant to drug-eluting and biodegradable stents, but additional recommended tests for these devices are outlined in drug-eluting stent draft guidance, FDA notes. The document supersedes January 2005 guidance

Related Content

Topics

UsernamePublicRestriction

Register

MT028203

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel