Bureau of EMS Updates and Announcements

FDA Warning Letter

King LT(S)-D Oropharyngeal Airway

The FDA has issued an enforcement warning letter to King Systems Corporation regarding the marketing of the King LT(S)-D oropharyngeal airway for uses that the FDA has not approved.

Manufacturer Recalls

Philips Heartstart Fr2+ Automated External Defibrillators

Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs are used by trained responders and designated response teams to help treat sudden cardiac arrest.

The recalled units (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) were manufactured between May, 2007 and January, 2008. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs and set up a page on the Philips Web site -- www.philips.com/FR2PlusAction -- with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.

Physio-Control Inc., Lifepak CR Plus AED

An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Read the complete MedWatch Safety Summary, including links to the FDA notice at:

ZOLL AED Plus Defibrillator

ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter at link below for details.

Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer letter at:

Welch Allyn AED 10

Welch Allyn announced a voluntary recall on February 25, 2009 for 14,054 AED 10 and MRL JumpStart external defibrillators made between Oct. 3, 2002, and Jan. 25, 2007.

Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs)

Audience: Emergency services personnel, risk managers, consumers

[Posted 03/07/2007] Defibtech and FDA notified healthcare professionals of a worldwide recall of 42,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software may allow a self-test to clear a detected low battery condition. The operator may be unaware of the low battery and the device may not deliver a defibrillation shock, resulting in failure to resuscitate a patient. The company 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. The devices were distributed to schools, fire & EMS, businesses, health clubs and hospitality companies.

MRL/Welch Allyn AED 20 Automatic External Defibrillators

Audience: Emergency Services personnel and risk managers

[Posted 09/18/2007] FDA issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer for a replacement.

Welch Allyn AED 10 Automatic External Defibrillators

Audience: Emergency services personnel, risk managers, and consumers

[Posted 11/05/2007] FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.

ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP): S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage

Audience: Consumers, respiratory healthcare providers, and risk managers

[Posted 04/24/2007] ResMed and FDA notified consumers and healthcare professionals of a worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator. See recall notice for serial numbers for affected S8 models.

Patients may continue to use their S8 flow generators until they receive a replacement device. As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell. Patients should not use supplemental oxygen with an affected device; patients using supplemental oxygen should immediately contact their home healthcare provider for a replacement.