Philips—Sterilizable Internal Defibrillator Paddles: Insulation between Conductors in Switched Paddles May Break Down over Multiple Use Cycles; Manufacturer Issues Reminder to Perform Required Checks
September 30, 2020 | Risk Management News
ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at firstname.lastname@example.org.
In a September 4, 2020, Urgent Medical Device Correction letter submitted by an ECRI member hospital and posted by he U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Philips states that the insulation between conductors in the above switched internal paddles may break down over multiple use cycles. Philips also states that this problem may not be detected by the existing tests identified in the Paddle Checks section of the instructions for use (IFU). A damaged paddle may not be able to deliver a shock to the patient with the intended energy. Early signs of insulation breakdown can be detected by performing an insulation resistance test. Philips further states that this problem affects only the above switched paddles; however, Philips uses a common IFU with all models of sterilizable internal paddles (switched and switchless), and many users have both types of paddles. Therefore, Philips determined that all recipients of the common IFU should be notified to update their copies, even though the additional test is recommended only for switched internal paddles. All internal paddles wear out over time and may no longer perform as intended. The manufacturer has not confirmed the...