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Pacific West Medical

PACIFIC WEST MEDICAL, INC. · Model PWMINFANT-Philips · UDI-DI 00852397008035

LDD Prescription

510(k) clearances

16,581

Adverse events (943 deaths)

Recalls

Facilities

Description

The Pacific West Pediatric (Infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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 patients skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (100 joules). 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 manual defibrillators whose output is classified as low power (360 joule maximum), and not for AED use. The defibrillator needs to be manually adjusted to 100 joules or lower depending on the actual weight of patient. Comparable with Philips Plug Style connector models of monophasic and bi-phasic defibrillators.

Recalls

Date	Firm	Reason
2024-10-28	Remote Diagnostic Technologies Ltd.	Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
2024-08-09	Physio-Control, Inc.	Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizabl
2024-05-09	Remote Diagnostic Technologies Ltd.	Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions
2023-05-08	Remote Diagnostic Technologies Ltd.	Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error m
2022-01-28	Remote Diagnostic Technologies Ltd.	Distribution of Defibrillators that are not approved or cleared for distribution US Market.
2020-11-17	Remote Diagnostic Technologies Ltd.	A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out
2014-11-06	ConMed Corporation	Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result
2014-11-06	ConMed Corporation	Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result
2013-04-26	Cardio Medical Products	Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O
2011-03-09	ConMed Corporation	The product lot was assembled with an R2 Connector, rather than a Zoll 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.