Physio-Control LIFEPAK 1000 Defibrillator 의 안전성 경고

Safety alert

2014-06-06

2014-06-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140606.html

Medical device safety alert: physio-control lifepak 1000 defibrillator the united states food and drug administration (fda) has issued a medical device safety alert concerning lifepak 1000 defibrillator [affected battery part number: 320371500xxx], manufactured by physio-control, inc. the manufacturer has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. a software malfunction in the lifepak 1000 defibrillator causes the readiness display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. the manufacturer advises users that batteries at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the "ok" symbol is present. users should always carry a spare fully-charged battery, as stated in the operating instructions. the manufacturer continues to investigate this issue and will have a follow up communication with users regarding this issue. this communication may include updates to operating instructions, software updates or additional maintenance instructions. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1660-2014&w=06042014&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 june 2014.