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CPRmeter

Laerdal Medical AS · Model 801 · UDI-DI 07045432055290

LIX Prescription

510(k) clearances

153

Adverse events (2 deaths)

Recalls

Facilities

Description

The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided in accordance with the 2010 versions of the guidelines for resuscitation published by the International Liaison Committee on Resuscitation (ILCOR), American Heart Association (AHA), and European Resuscitation Council (ERC) (hereinafter referred to as “CPR Guidelines”). The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. The CPRmeter device provides feedback on CPR via a display panel to improve responders’ compliance with CPR Guidelines.

Recalls

Date	Firm	Reason
2018-01-29	Philips Electronics North America Corporation	Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent
2018-01-29	Philips Electronics North America Corporation	Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent

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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.