Physio-Control Launches Voluntary Field Action for Specific Production Lots of Infant/Child Reduced Energy Defibrillation Electrodes Produced by Cardinal Health

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Announcement

Physio-Control announced today that the company is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health.

The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.

The defibrillation electrodes are used only with LIFEPAK EXPRESS® AED, LIFEPAK CR® Plus AED, LIFEPAK® 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected. There have been no customer complaints reported for this issue.

The company is contacting customers to notify them of the issue, and to provide customers with correct electrode placement instructions to be included with the AEDs until they receive their corrected defibrillation electrodes. Physio-Control will provide replacement products for all unused affected defibrillation electrodes.

As an alternative, if customers decide not to use the affected defibrillation electrodes and they do not have a spare set of infant/child defibrillation electrodes, based on American Heart Association (AHA) and European Resuscitation Council (ERC) 2015 Guidelines, ^1,2 customers may consider the use of adult defibrillation electrodes until they receive their replacement set of infant/child defibrillation electrodes.

Affected customers will be notified by letter. Information about this notice is available at: https://www.physio-control.com/ProductNotices.aspx. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday - Friday, or by email to [email protected] or fax to 1-866-448-9567.

In addition to contacting Physio-Control, any potential quality problems or adverse reactions or events associated with the use of a Physio-Control product may be reported to the U.S. Food and Drug Administration's MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm, by phone 1-800-332-1088 or fax 1-800-FDA-0178.

¹ Atkins D, Berger S, Duff J, et al. American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Care. Circulation. Part 11: Pediatric Basic Life Support and Cardiopulmonary Resuscitation Quality. 2015;132(18 suppl 2): pS525.

² Ian K. Maconochie, Robert Bingham et al. European Resuscitation Council Guidelines for Resuscitation 2015 Section 6. Pediatric life support. Resuscitation 95 (2015) 223-248: p235.