—#183714

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187
Affected lot / code info: All units manufactured and distributed January 2015 to August 2020.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Urgent Medical Device Correction notification letters dated 9/4/20 were sent to customers. Insert a copy of the attached Instructions for Use Addendum: Sterilizable Defibrillator Paddles: Insulation Resistance Check for Switched Internal Paddles to the Sterilizable Defibrillator Paddles IFU. Follow the Instructions for Use, Paddles Checks section. The Paddle Checks activities include: Mechanical Check, Visual Inspection, Functional Check, Continuity Check, and Insulation Resistance Check. Perform these activities to confirm the paddles are safe and ready for use. The Insulation Resistance Test is to be applied only to Switched Internal Paddles (M4741A, M4742A, M4743A, and M4744A). Continue to perform the Paddles Checks activities as recommended in the IFU, before use as this reduces the risk of a failure as the paddles age. If your Internal Paddles fail any of these Paddle Checks, the IFU directs that the paddles should be removed from service and replaced. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recalI.response@phiIips.com. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by regular mail or by fax.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Global Distribution. US Nationwide.

Timeline

Recall initiated: 2020-09-14
Terminated: 2022-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.