Recall Z-1664-2011
Jolife AB · initiated February 8, 2011
Product
LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". Designed to uninterrupted chest compressions at a consistent rate and depth.
Codes / lots: SERIAL NUMBERS for 546 UNITS DISTRIBUTED BY PHYSIO-CONTROL IN THE US: 30090182, 30090188, 30090216, 30090232, 30090242, 30090273, 30090275, 30090276, 30090277, 30090278, 30090279, 30090280, 30090281, 30090282, 30090284, 30090285, 30090286, 30090305, 30090314, 30090318, 30090325, 30090327, 30090328, 30090331, 30090333, 30090335, 30090426, 30090428, 30090429, 30090430, 30090432, 30090433, 30090434, 30090436, 30090437, 30090438, 30090439, 30090440, 30090442, 30090443, 30090445, 30090448, 30090449, 30090450, 30090451, 30090452, 30090453, 30090454, 30090457, 30090458, 30090459, 30090460, 30090461, 30090471, 30090499, 30090500, 30090501, 30090502, 30090503, 30090504, 30090505, 30090506, 30090507, 30090508, 30090509, 30090510, 30090511, 30090512, 30090513, 30090514, 30090515, 30090516, 30090517, 30090550, 30090564, 30090565, 30090566, 30090567, 30090568, 30090569, 30090575, 30090577, 30090580, 30090581, 30090583, 30090584, 30090629, 30090633, 30090653, 30090661, 30090665, 30090666, 30090670, 30090671, 30090672, 30090673, 30090674, 30090675, 30090676, 30090677, 30090678, 30090679, 30090680, 30090681, 30090682, 30100752, 30100753, 30100754, 30100755, 30100756, 30100757, 30100758…
Reason for recall
LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.
FDA-determined cause: Other
Action taken
Medical Device Correction letter, dated February 2011, was sent to customers and states that Jolife AB with the servicing support assistant of Physio-Control is conducting a voluntary upgrade of the LUCAS 2 Chest Compression System with the Serial number range of 30090016 through 30101932. Consignees were advised to keep LUCAS 2 in service and continue to use it in accordance with the Instruction for Use, Section 3.8-Safety Precautions. WARNING-MALFUNCTION. If there are interruptions, or the compressions are not sufficient or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start Manual chest compression. Physio-Control service representative will contact the consignees to schedule a service call to replace the affected battery connector board in the hood of the device. The new connector board will include a new probe design in which current cannot affect the spring. Consignees can contact Physio-Control Technical Support at 1-800-442-1142, #5 between 6 am-4 pm (Pacific Time), Monday-Friday or visit the website www.physio-control-notices.com/LUCAS2. If customers no longer have the affected device or the device location has changed they should contact Physio-Control Technical Support.
Details
- Recall number
- Z-1664-2011
- Initiated
- February 8, 2011
- Posted by FDA
- March 16, 2011
- Terminated
- April 24, 2012
- Product code
- DRM – Compressor, Cardiac, External
- Quantity
- 1843 units
- Distribution
- Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
- Recalling firm
- Jolife AB, Lund