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CPRmeter 2 (Multi-bundle)

Laerdal Medical AS · Model 801 · UDI-DI 07045432073355

LIX Prescription

510(k) clearances

153

Adverse events (2 deaths)

Recalls

Facilities

Description

The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provide real-time feedback on manual chest compression (i.e depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compression and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.

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.