Recall Date: 03/20/2020 |
Title: 2020 Component Wear that prevents patient Connection |
Units: LIFEPAK 500 |
Issue: LIFEPAK 500 AEDs in high-use enviroments (Emergency Medical Services) may ot detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form result in the device not recognizing a patient is connected. When the circumstance arises, the device will provide the user the “CONNECT ELECTRODES” message. |
Fix: Replace AED with a FDA approved device. |
Alert Documentation |