Adult/Child, radiolucent, defib electrodes w/ 10 foot lead wire with Zoll connec
HEART SYNC INC · Model T100AC-ZOLL-10 · UDI-DI 00854664006201
Description
The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult/child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Comparable with Zoll connector models of monophasic and bi-phasic defibrillators.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-31 | ConMed Corporation | The specific lot was assembled without the rivet cover. |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until i |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until i |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-06-16 | Bio-Detek, Inc. | Multi-function electrode programmed as a Pediatric instead of Adult |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2005-11-18 | Philips Medical Systems | The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector |
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