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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 63139
Product Type Devices
Status Ongoing
Recalling Firm Heartsine Technologies, Limited
City Belfast
Country GB
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Class I Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device. If the device does not detect that the audible prompts are followed (e.g., a patient is connected to the electrodes to allow the device to read the patient's ECG and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power. this sequence of on-off events can happen repeatedly or intermittently. If this condition is undetected, the battery will eventually become completely depleted. In worst-case situations, it is possible that the battery could be depleted below the minimum battery capacity to allow for the delivery of therapy within a week. However, a device experiencing this issue will be capable of delivering therapy provided that an adequate power source is available. Devices potentially subject to this issue were manufactured between August 2004 and December 2010 and have a warranted life of up to 7 years. Issue 2 (Battery Management Software Issue): Certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. This may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device may not deliver any shocks, or it may only deliver one shock before turning itself off. If this occurs, delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 Joules. Once the device has experienced this condition, it is more likely to experience it again. This condition can occur when the installed PAD-PAk is an 800mAh capacity battery. This software version was distributed until the end of December 2010. Devices containing software version 1.4.2/3.2.0 or higher are not susceptible to this issue. 81,982 in total Z-0124-2013