Important Safety Alerts

The Health Sciences Authority (HSA) has issued a medical device safety alert concerning FRED easy, manufactured by Schiller Medical SAS [Reference: 4-07-0001; Lot Number HYB 16-0056, HYB 16-0057, HYB 16-0058 and HYB 16-0059; between October 1, 2016 and January 15, 2017].

According to the manufacturer, users have reported some new batteries causing the failure "BATTERY EMPTY" when inserted into a defibrillator FRED easy. Batteries with this fault cannot be used. The fault is detected automatically by the FRED easy when the battery is inserted into the device.

The batteries of these Lots must be tested, using the procedure described below, to verify that they can be used in their FRED easy:

• Insert the battery into FRED easy (see section 3.1 "Inserting the battery" in the FRED easy user manual). The unit performs its self-test. At the end of the self-test, it shuts down and its green LED flashes: In this case, the battery is free from defects and can be used without limitation.
• However, if after the self-test of FRED easy the green light remains off and the display shows: the battery is defective. In this case, contact SCHILLER Distributor immediately, to get replacement.

For details, please refer to the HSA website:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Product_Owners_FSN/2017/january.html

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 6 February 2017