The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning FRED easy & FRED easy Life defibrillators manufactured by Schiller Medical.
According to Schiller Medical, two problems have been identified regarding "Transistor Charge Error" message and quality of the electrodes.
Transistor Charge Error:
- On some devices, during use, or during a self test, a message "Transistor Charge Error" has occurred. In the analysed cases (field and laboratory results), all occurrences were "false positive", the devices were not affected by a failure. As a consequence, the device is unavailable until it is restarted. The occurrence of the failure is estimated to 0.2%.
- The corrective action consists in a software update, which prevents the occurrence of the "false positive".
Electrodes:
- A decline in the quality, before expiry date, has been observed for some Schiller electrodes manufactured by Nessler (P/N 0-21-0000, 0-21-0003, 0-21-0020, 0-21-0021, 0-21-0013, 0-21-0024, 2.155056, 2.155057, W1410241, W1404262). The consequences were a decrease of survival chances for some patients, due to the lack of heart rhythm analysis.
- All Schiller electrodes which are still on the market, with a valid expiry date and manufactured by Nessler, will be exchanged by new Schiller electrodes manufactured by Leonhard Lang.
According to the local supplier, the affected products have been distributed in Hong Kong. For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 22 May 2012