Alerta De Seguridad para Product: LIFEPAK 1000 DESFIBRILLATOR. Models: 99425-000149; 99425-00148. Anvisa Registration No. 10339190300.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The manufacturer of the product (Physio-Control Inc.) became aware of a number of occurrences where AED LIFEPAK 1000 was unable to provide the patient with the necessary defibrillation therapy due to poor battery condition. We found this to be because the batteries were not replaced when they reached the low or very low charge level as indicated on the device's readiness screen. The market investigations have determined that the confusing operating instructions and malfunction of the device software contribute to the failure of the batteries to be replaced at the right time. Other contributing factors include the absence of a fully charged spare battery, contrary to the recommendations in the operating instructions. Physio-Control / Medtronic said it will implement a software update on all affected devices, free of charge, over the next few years. Customer device upgrades will be prioritized, based on the age of the devices, as well as information submitted in response to the attached confirmation form. Company code for field action: FA265 Phase II. #### UPDATED ON 7/24/2017, the company submitted the field action completion report verifying the sending of the customer safety notice.