Samaritan PAD 300/PAD 300P Automated External Defibrillator 의 안전성 경고

Safety alert

2012-09-19

2012-09-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120919.html

Medical device safety alert: heartsine samaritan pad 300/pad 300p automated external defibrillator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 300/pad 300p automated external defibrillator manufactured by heartsine technologies ltd. the manufacturer has initiated a voluntary correction regarding the following two issues that could affect ability of the device to deliver therapy to a patient in a sudden cardiac arrest event, if needed: issue 1 (on/off issue): the device may turn itself on without input from the user. when this occurs, the normal sequence of audible prompts will be emitted from the device. if the device does not detect that the audible prompts are followed (e.G., that a patient is connected to the electrodes to allow the device to read the patients’ ecg and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power. this sequence of events can happen repeatedly or intermittently. if this condition continues undetected, the battery will eventually become completely depleted. in worst-case situations the battery could, within a week, be depleted below the minimum battery capacity necessary to allow for the delivery of therapy. in such circumstances, the device will subsequently be capable of delivering therapy if an adequate power supply is provided. devices potentially affected by the on/off issue were manufactured between august 2004 and december 2010 and have a warranted life of up to 7 years. issue 2 (battery management software issue): certain pad 300/pad 300p devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. the issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. this may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. if the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks but it is possible that the device will only deliver one shock before turning itself off. if this occurs, delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 joules. once the device has experienced this condition, it is more likely to experience it again. this condition can occur where the installed pad-pak has already been partially depleted due to normal battery depletion or where the installed pad-pak is an 800 mah capacity battery. this software version was distributed until end december 2010. devices containing software version 1.4.2 / 3.2.0 or higher are not susceptible to this issue. no other heartsine technologies ltd. automated external defibrillator products are affected by either issue addressed in this letter. for issue 1, the manufacturer will provide users a reserve 1500 mah pad-pak battery which is to be held in reserve in the zippered pouch on the back of the carry case of the device. for issue 2, the manufacturer will provide users a data cable that will allow them to download the current version of the device's battery management software (http://www.Heartsine.Com/recall/software_updates). in addition, a hang tag is provided with the field safety notice to provide instruction for users on how to install the reserve pad-pak battery should the existing battery appear to lack sufficient battery power during a patient event and the hang tag will also be provided to users with the reserve battery inside the upgrade kit. according to the distributor, the affected devices were not distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con184701 if you are in possession of the product, please contact your supplier for necessary actions. posted on 19 september 2012.