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Physio-Control Launches Voluntary Field Action for LIFEPAK 1000 Defibrillator

Physio Control Defib Recall January 2017

Physio-Control announced today that the company is launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.

The company is notifying LIFEPAK 1000 customers of an issue that may affect the readiness of the device. The company has received 34 reports where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. A defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. The company is aware of 8 adverse events related to this issue.

The company has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. This condition can occur over time in LIFEPAK 1000 devices that are exposed to vibration and have a battery installed for long periods of time. This issue can potentially affect any LIFEPAK 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the LIFEPAK 1000 Defibrillator Operating Instructions, are more susceptible to this issue.

The company is contacting customers and advising them to immediately remove and reinstall the battery from their device(s). Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation. The company will provide customers with updated information regarding the timing for this device correction at the website URL shown below, when it is available.

Information about this notice is available at: www.physio-control.com/lifepak1000-274. Affected customers will be notified by letter. 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 rsrecalls@physio-control.com 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.

About Physio-Control

Physio-Control is the world’s leading provider of professional emergency medical response solutions that predict or intervene in life-threatening emergencies. The company’s products include LIFEPAK® monitor/defibrillators and automated external defibrillators (AED), LUCAS® Chest Compression Systems, the LIFENET® System, HeartSine® AEDs and more. Learn more at www.physio-control.com, or connect on Facebook, LinkedIn or Twitter.

About Hourigan, Kluger & Quinn, PC

Hourigan, Kluger & Quinn is considered one of the top civil litigation and commercial law firms in Northeastern Pennsylvania. The firm’s Personal Injury Team, led by Attorney Joe Quinn, has won some of the largest verdicts and settlements in the region's history, totaling over a half billion dollars on behalf of injured clients. HKQ Law was recently recognized for one of the top 20 Verdicts in Pennsylvania, 2015.

The Personal Injury Team focuses on a wide array of personal injury claims and civil litigation, including medical malpractice, auto and truck accidents, aviation accidents, unsafe vehicles, dangerous or defective products, workplace injuries (worker's compensation), construction site accidents, claim denials by insurance companies, dangerous drugs, defective children's products, nursing home abuse and neglect, and falls due to unsafe conditions (slip and fall).

Attorney Joseph A Quinn is one of only 100 attorneys in the United States (and one of only three in Pennsylvania)
honored with membership in the Inner Circle of Trial Advocates, and one of only 500 attorneys worldwide chosen to be a Fellow of the International Academy of Trial Lawyers. He has been a Pennsylvania Super Lawyer every year since the program began and has been listed in The Best Lawyers in America every year since the publication was established in 1987. Best Lawyers also named him top personal injury attorney for Northeastern Pennsylvania and the Lehigh Valley. In addition, Best Lawyers, in conjunction with U.S. News & World Report, has designated HKQ a Tier 1 Best Law Firm for personal injury and medical malpractice litigation in Northeastern Pennsylvania and the Lehigh Valley.

Since the inception of the firm, the Commercial / Corporate Team led by Attorney Allan Kluger has provided comprehensive, integrated legal services to many of Northeastern and Eastern Pennsylvania's largest corporations, businesses, banks, non-profits and institutions, handling matters involving labor and employment, wills, trusts and estate planning, estate administration, elder law, commercial transactions, residential and commercial real estate, zoning, land use and development, telecommunications, mediations and arbitrations, commercial litigation, title insurance, business planning and business succession, corporate/business structuring, employment discrimination law for employers, banking, creditor’s rights, finance, lender liability defense, covenants not to compete, construction law, mergers and acquisitions and other business matters.

				

 

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