mrx lithium ion batteries 의 안전성 경고

Safety alert

2014-02-20

2014-02-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220.html

Medical device safety alert: philips heartstart mrx lithium ion batteries medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning heartstart mrx lithium ion batteries with battery model number m3538a revision j and the affected battery serial numbers are: 11327-0019-p, 11315-0023-p, 11315-0027-p, 11315-0031-p, 11315-0032-p, 11315-0033-p, 11315-0036-p, 11315-0109-p, 11315-0214-p, 11315-0219-p, 11315-0391-p, 11322-0084-p, 11322-0088-p, 11327-0043-p, 11327-0044-p; or within range 11335-xxxx-p to 13214-xxxx-p according to the manufacturer, the philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from radio frequency (rf) energy sources. examples of equipment that can cause electromagnetic interference are medical devices, cellular products, information technology equipment and radio/television transmissions. the manufacturer provides users with the following information and advice: the condition can be avoided by operating the device on ac or external dc power or by the following actions when operating on battery power: 1) before placing a heartstart mrx into use, insert a fully-charged battery with five solid green lights on the battery fuel gauge when the fuel gauge button is pressed; 2) if the device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. if there are no lights, insert a fully-charged mrx battery fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. the manufacturer advises users to see the heartstart mrx instructions for use for the minimum recommended separation distance between rf communications equipment and the heartstart mrx. furthermore, the manufacturer will replace affected batteries. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 february 2014.