—#70502

Product

Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.

FDA product code: NSA — Over-The-Counter Automated External Defibrillator
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K040904
Affected lot / code info: SN for Philips "HeartStart Home": A05I-00017, A05I-00403, A05I-00412, A05I-00413, A05I-00414, A05I-00415, A05I-00417, A05I-00418, A05I-00419, A05I-00420, A05I-00421, A05I-00423, A05I-00424, A05I-00425, A05I-00426, A05I-00428, A05I-00429, A05I-00430, A05I-00431, A05I-00433, A05I-00434, A05I-00435, A05I-00436, A05I-00437, A05I-00438, A05I-00439, A05I-00440, A05I-00441, A05I-00442, A05I-00443, A05I-00444, A05I-00445, A05I-00446, A05I-00447, A05I-00448, A05I-00449, A05I-00450, A05I-00476, A05I-00496, A05I-00501, A05I-00503, A05I-00504, A05I-00505, A05I-00506, A05I-00509, A05I-00511, A05I-00512, A05I-00513, A05I-00515, A05I-00520, A05I-00528, A05I-00529, A05I-00530, A05I-00531, A05I-00535, A05I-00537, A05I-00539, A05I-00540, A05I-00541, A05I-00542, A05I-00544, A05I-00545, A05I-00549, A05I-00604, A05I-00605, A05I-00607, A05I-00609, A05I-00610, A05I-00612, A05I-00613, A05I-00614, A05I-00656, A05I-00665, A05I-00666, A05I-00667, A05I-00668, A05I-00669, A05I-00670, A05I-00671, A05I-00672, A05I-00673, A05I-00674, A05I-00676, A05I-00677, A05I-00678, A05I-00679, A05I-00680, A05I-00681, A05I-00682, A05I-00683, A05I-00684, A05I-00685, A05I-00686, A05I-00687, A05I-00688, A05I-00689, A05I-00690, A05I-00691, A05I-00692, A05I-00693, A05I-00694, A05I-00695, A05I-00697, A05I-00698, A05I-00699, A05I-00700, A05I-00747, A05I-00749, A05I-00750, A05I-00751, A05I-00752, A05I-00753, A05I-00754, A05I-00755, A05I-00756, A05I-00757, A05I-00758, A05I-00759, A05I-00760, A05I-00761, A05I-00762, A05I-00764, A05I-00771, A05I-00772, A05I-00776, A05I-00777, A05I-00778, A05I-00779, A05I-00780, A05I-00785, A05I-00808, A05I-00810, A05I-00813, A05I-00814, A05I-00815, A05I-00817, A05I-00818, A05I-00819, A05I-00820, A05I-00821, A05I-00822, A05I-00823, A05I-00824, A05I-00828, A05I-00830, A05I-00832, A05I-00833, A05I-00837, A05I-00841, A05I-00842, A05I-00843, A05I-00844, A05I-00845, A05I-00846, A05I-00848, A05I-00849, A05I-00850, A05I-00868, A05I-00871, A05I-00874, A05I-00877, A05I-00878, A05I-00882, A05I-00883, A05I-00884, A05I-00885, A05I-00886, A05I-00887, A05I-00888, A05I-00889, A05I-00890, A05I-00891, A05I-00892, A05I-00893, A05I-00894, A05I-00895, A05I-00896, A05I-00897, A05I-00898, A05I-00899, A05I-00900, A05I-00901, A05I-00902, A05I-00903, A05I-00904, A05I-00905, A05I-00906, A05I-00907, A05I-00909, A05I-00910, A05I-00911, A05I-00912, A05I-00913, A05I-00914, A05I-00915, A05I-00916, A05I-00917, A05I-00918, A05I-00920, A05I-00921, A05I-00922, A05I-00923, A05I-00942, A05I-01010, A05I-01195, A05I-01257, A05I-01267, A05I-01288, A05I-01289, A05I-01290, A05I-01292, A05I-01293, A05I-01295, A05I-01296, A05I-01298, A05I-01299, A05I-01357, A05I-01380, A05I-01381, A05I-01397, A05I-01399, A05I-01444, A05I-01450, A05I-01487, A05I-01494, A05I-01501, A05I-01502, A05I-01503, A05I-01506, A05I-01507, A05I-01513, A05I-01517, A05I-01520, A05I-01521, A05I-01522, A05I-01524, A05I-01525, A05I-01547, A05I-01549, A05I-01568, A05I-01576, A05I-01579, A05I-01582, A05I-01584, A05I-01587, A05I-01591, A05I-01602, A05I-01606, A05I-01607, A05I-01608, A05I-01609, A05I-01610, A05I-01611, A05I-01612, A05I-01613, A05I-01614, A05I-01615, A05I-01616, A05I-01626, A05I-01635, A05I-01636, A05I-01637, A05I-01653, A05I-01656, A05I-01664, A05I-01665, A05I-01667, A05I-01670, A05I-01671, A05I-01680, A05I-01684, A05I-01685, A05I-01686, A05I-01715, A05I-01718, A05I-01720, A05I-01722, A05I-01723, A05I-01731, A05I-01732, A05I-01734, A05I-01740, A05I-01751, A05I-01798, A05I-01799, A05I-01800, A05I-01851, A05I-01852, A05I-01853, A05I-01858, A05I-01859, A05I-01860, A05I-01861, A05I-01862, A05I-01864, A05I-01865, A05I-01866, A05I-01867, A05I-01868, A05I-01872, A05I-01873, A05I-01876, A05I-01877, A05I-01919, A05I-01920, A05I-01922, A05I-01924, A05I-01926, A05I-01941, A05I-01943, A05I-01953, A05I-01956, A05I-01957, A05I-01958, A05I-01959, A05I-01960, A05I-01961, A05I-01963, A05I-01964, A05I-01965, A05I-01966, A05I-01968, A05I-01971, A05I-01972, A05I-02019, A05I-02158, A05I-02232, A05I-02247, A05I-02272, A05I-02274, A05I-02277, A05I-02278, A05I-02279, A05I-02281, A05I-02287, A05I-02292, A05I-02314, A05I-02718, A05I-02833, A05I-02840, A05I-02850, A05I-02851, A05I-02856, A05I-02873, A05I-02877, A05I-02960, A05I-02961, A05I-02985, A05I-02993, A05I-03011, A05I-03032, A05I-03053, A05I-03069, A05I-03098, A05I-03099, A05I-03101, A05I-03114, A05I-03117, A05I-03123, A05I-03205, A05I-03215, A05I-03216, A05I-03217, A05I-03357, A05I-03472, A05I-03473, A05I-03523, A05I-03524, A05I-03525, A05I-03561, A05I-03563, A05I-03566, A05I-03572, A05I-03584, A05I-03599, A05I-03601, A05I-03774, A05I-03775, A05I-03776, A05I-03777, A05I-03784, A05I-03798, A05I-03851, A05I-04019, A05I-04136, A05I-04290, A05I-04765, A05I-04769, A05I-04771

Why it was recalled

Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.

Root cause (FDA determination)

Component design/selection

Action the firm took

Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).

Recalling firm

Firm: Philips Medical Systems
Address: 2301 5th Ave, Ste 200, Seattle, Washington 98121

Distribution

Distribution pattern: Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.

Timeline

Recall initiated: 2008-04-30
Posted by FDA: 2008-07-09
Terminated: 2012-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.