FRED Easyport 의 안전성 경고

Safety alert

2016-05-18

2016-05-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160518c.html

Medical device safety alert: schiller fred easyport the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning fred easyport (an automatic external defibrillator) manufactured by schiller. the affected article number is 0.900000 and the affected products are sold from 2004 to 2016. according to the manufacturer, the device can be categorised into three categories according to its configuration: first category: has manual mode of analysis and can override the analysis in order to shock based on user’s decision. second category: has manual mode of analysis and shock delivery by user, if suggested by the device. analysis cannot be overridden but can be initiated again at any time.  third category: does automatic analysis every two minutes which cannot be overridden by user. the manufacturer has received an incident report relating to a device of the third category where the ecg trace showed a ventricular fibrillation. the device decided for a shock delivery correctly. during the loading of capacitor the device analysed further and due to the short change of rhythm the device diverted the shock internally and asked the user to resume cardiopulmonary resuscitation (cpr) immediately. the device in question (third category) had a special feature of automatic analysis every two minutes. however, the standard device (first and second categories) analyses upon pressing the “analysis” button. the user is prompted to do so every two minutes. in the present case the user got confused and did not allow for the further automatic rhythm analysis after two minutes. the user continued with cpr, so the device noted motion artefacts and thus could not analyse the trace anymore. therefore, no shock was delivered. the manufacturer advises that:- for the first and second categories of device: users can use the device without any restriction. however, new software upgrade to ver. 3.14 is recommended at next service of device. for the third category of device: new software upgrading shall be completed upon receipt from the manufacturer of the new software version 3.14. with the new software version 3.14, there will be no automatic re-analysis during charging of capacitor; therefore, this potential risk will be eliminated. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-9-may-13-may-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.