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U.S. Department of Health and Human Services

Class 2 Device Recall Physio Control LIFEPAK 1000 Defibrillator

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 Class 2 Device Recall Physio Control LIFEPAK 1000 Defibrillator see related information
Date Posted May 23, 2014
Recall Status1 Open
Recall Number Z-1660-2014
Recall Event ID 67963
510(K)Number K042404  K1222600 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX

The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.

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Recalling Firm/
Manufacturer
Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
425-867-4000
For Additional Information Contact Technical Support Team
800-442-1142 Ext. 7
Manufacturer Reason
for Recall
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100
FDA Determined
Cause 2
Software Manufacturing/Software Deployment
Action On May 9, 2014 Physio-Control sent an Urgent Medical Device Recall Letter (dated May 2014) to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer notification letter will provide new instructions on how to check the functional and power readiness of the device and advise the customer on the actions to take based on the symbol displayed. Customers are asked to record the readiness indicator(s) shown on each device and fax the confirmation sheet back to Physio-Control at 1-866-448-9567. Customers are also directed to contact Physio-Control at 1-800-442-1142 to obtain replacement batteries, if needed. Customers are provided a Device Readiness Guide for use in interpreting the Readiness Display on the device, and are directed to refer to the Operating Instructions which were provided upon purchase. In addition to notifying Physio-Control of any potential quality problems or adverse reactions or events experienced associated to the use of these products, Physio-Control asks customers to report directly to the FDA through the MedWatch Adverse Reporting Program online, by regular mail or by fax. Physio-Control reminds customers that it is critically important in understanding what the device and battery indicators mean on your defibrillator and what actions you need to take as a result. At any time the battery charge can be verified by following the instruction provided on page 2-5 of the Operating Instructions. It is also important that you always carry a spare fully-charged battery, as stated in the Operating Instructions. Customers are directed to call Physio-Control at 1-800-442-1142, 6:00 a.m. to 4:00p.m. (Pacific), Monday - Friday for any further questions. ********************************************************************************************* On May 18, 2015, Physio Control sent the Urgent Medical Correction-Action Required LIFEPAK 1000 DEFIBRILLATOR to U
Quantity in Commerce 96,611 units total (40,974 in the US and 55,637 outside the US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, Espa¿a, FAROE ISLANDS, FINLAND, FRANCE, FRENCH GUIANA, FRENCH POLYNESIA, GABON, GEORGIA, GERMANY, GREECE, GUAM, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF, IRAQ, IRELAND, ISRAEL, ITALY, Japan, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACAU, MACEDONIA, THE FORMER YUGOSL, MALAYSIA, MALDIVES, MALTA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA FEDERATION, SAN MARINO, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, Suriname, South America, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
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