A Medical Device Daily

Defibtech (Guilford, Connecticut) reported that it has launched a recall of all of its Lifeline AED and ReviveR AEDTM semi-automatic external defibrillator products.

The recall affects all Lifeline and ReviveR AEDs with software versions 2.002 and earlier.

Defibtech said that the software for these devices may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a shock.

The FDA determined that this action is a Class I recall, indicating a probability that the problem could result in serious injury or death.

Defibtech said it notified its distributors and customers of the recall by letter on Feb. 22. The company said it determined the need for the recall after receiving three reports of malfunctions.

It said it is providing customers with a free software upgrade for all affected AEDs — available “within the next 10 weeks” — that can be installed in the field.

Defibtech said it has provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service.

Defibtech said it has sold about 42,000 units worldwide through distributors to schools, fire and emergency services, businesses, health clubs and hospitality companies. The products can be identified by the words Lifeline AED and ReviveR AEDTM.

BSD Medical (Salt Lake City) reported that it has received a warning letter from the FDA, and that its “principal observations” relate to errors in the conduct of a clinical study at a single site.

BSD said the letter addresses three “general areas: monitoring, securing investigator compliance with the protocol and reporting. These concerns, it says, “are limited to clinical study conduct and have nothing to do with the safety, efficacy, quality, design or manufacture of BSD’s equipment.”

It said it is provides the agency with “a complete report” concerning the actions and procedures it has taken to address the problems cited in the letter.

The data from this site, BSD said, have not been used as the basis for any FDA approval of its product, “nor have data from the site been otherwise used by BSD to statistically support the efficacy of BSD systems in treating patients.”

It also asserts that it has not funded any of the research at this site and that the site has been closed to treating patients since Aug. 31, 2006.

BSD is conducting a study in Europe and has submitted a premarket approval application for its BSD-2000 — a system for delivering hyperthermia to make inoperable tumors removable via surgery — based on a pivotal study in Europe, but it said this study is not the subject of the FDA letter.

“BSD is committed to operating in full compliance with applicable FDA regulations and expects that the actions taken and the systems and procedures implemented in response to the FDA’s letter will strengthen the company’s clinical research going forward,” it said in a statement.

BSD develops systems used to deliver focused thermal treatments for cancer.