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Zensor electrode

INTELESENS LIMITED · Model PN1360 · UDI-DI 05060484630099

MLN Prescription

510(k) clearances

1,347

Adverse events (194 deaths)

Recalls

Facilities

Description

The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 6 days before a replacement is required.

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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Data 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.