Philips North America, LLC: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.

Agency Publication Date: October 23, 2020

Affected Products

Product: Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.

All units manufactured and distributed January 2015 to August 2020.

Product: Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.

All units manufactured and distributed January 2015 to August 2020.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86441

Status: Resolved

Manufacturer: Philips North America, LLC

Manufactured In: United States

Units Affected: 2 products (8,942; 2,202)

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Sources: FDA iRES · Raw API Response

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Affected Products

All units manufactured and distributed January 2015 to August 2020.