Home › Element Science, Inc. › Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel")
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel")
Element Science, Inc. · Model ES-2 · UDI-DI 00850047782007
MVK
Prescription
0
510(k) clearances
149,799
Adverse events (3,767 deaths)
5
Recalls
10
Facilities
Description
ES-2 Reusable Defibrillator Unit, Packaged
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-12 | Zoll Manufacturing Corp. | Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure |
| 2010-09-24 | Zoll Lifecor Corporation | The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious p |
| 2008-10-21 | Zoll Lifecor Corporation | The charging circuit will not shut down properly. |
| 2007-09-14 | Zoll Lifecor Corporation | Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to dischar |
| 2007-04-27 | Zoll Lifecor Corporation | The electrodes do not properly release conductive gel |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.