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The initial call came in on (b)(6) 2014 for a (b)(6) year old female in cardiac arrest at a healthcare facility.Patient was 165 cm tall and weighed (b)(6).She had a history of chronic pancreatitis of antecedent (autoimmune disease) and was on the following medications: oflocet, amoxicillin clavulanate, hydroxychlorquine, metoclopramide and phytomenadione.Patient was on a spine bed and had a cardiac arrest in the intensive care unit.The emergency resuscitation service was also on scene at the time of the cardiac arrest.Manual cpr was initiated as soon as the patient was found in cardiac arrest (exact length of time was not provided).Manual cpr was stopped for just a few minutes while the patient was being positioned on the autopulse platform.There were no issues with deployment of the platform.The platform ran for 25 minutes and then stopped in the operating room.The staff replaced the battery with another one.Manual cpr was performed for 2 minutes while the battery was being replaced.The platform ran for a few minutes before the staff discontinued therapeutic support.The course of treatment in the er included intubation and administration of adrenaline and noradrenaline.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead by the intensive care physician in the operating room on the same day.There were no signs or symptoms of trauma.The cause of cardiac arrest is unknown.Customer indicated that there was less chance to perform an extracorporeal membrane oxygenation (ecmo) because of the patient's declining ph and lactate.Per the customer, the patient died due to a progression of her illnesses.An autopsy report was performed but is not available.
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The doctor also indicated that the batteries were last charged the night before the incident.The hospital performs weekly checks but not daily ones.However, they have a 4 battery rotation which is performed on a daily basis.The autopulse platform in complaint was returned to zoll on 11/14/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the load plate cover was defective and the battery partition cover was missing.The physical damages found during visual inspection are not related to the reported event of the platform suddenly stopping without audible and visual alarm.The damages appear to have been caused by normal wear and tear (autopulse manufactured in january of 2007).A review of the autopulse platform's archive was performed and the reported complaint of the platform stopping compressions was confirmed.The archive data shows that warning 1 - low battery warning message, user advisory (ua) 4 (battery charge state too low (replace battery)) and ua 2 (compression tracking error) occurred on the reported event date of (b)(6) 2014.Review of the platform's archive shows that warning 1 and ua 4 faults occurred on the reported event date with li-ion battery with s/n (b)(4).The archive shows that this li-ion battery was fully charged and was used for deployment on (b)(6) 2014.The platform performed about 3100 compressions on a medium-sized patient for about 40 minutes until the low voltage battery warning was issued.Please note that the functional time for a fully charged battery is 30 minutes.Therefore, the battery used in this event functioned as intended.When the low voltage battery warning message was issued, the autopulse platform produced an audible sound and displayed a "low battery" warning on the control panel display of the platform.These messages are indicative of a battery that requires replacement due to a low charge state.If the battery continues to be used and not replaced with a fully charged battery, ua 4 will be exhibited.Ua 4 conveys that the battery is at a low charge state and cannot be used to be perform additional compressions.Eventually when the ua 4 fault was exhibited, the customer removed li-ion battery with s/n (b)(4) and replaced it with a fully charged battery (s/n (b)(4)) without powering off the autopulse platform.When the customer performed this action, the autopulse displayed a "battery lost" message.The cause of this message was due to the battery being removed from the autopulse platform before the platform was powered down.After li-ion battery (s/n (b)(4)) was inserted into the autopulse platform, active operation of the platform was re-initiated.The battery performed compressions for 15 seconds until the ua 2 fault message was exhibited.The customer properly realigned the patient on the autopulse platform and use of the autopulse continued.The platform ran for about 10 minutes in which it did about 763 compressions without issues.An investigation conducted using the batteries' serial number (s/n (b)(4)), found that these batteries were within their expected life span of 2-4 years (manufacture date: 12/2012).These batteries were also appropriately test cycled.However, it appeared that daily swaps and checks were not consistently performed.The autopulse archive shows one instance in which li-ion battery, s/n (b)(4) was put into the platform on 10/28/2014 and remained in the device until 10/30/2014.This means that the battery was in the platform for two days before it was removed from the platform.Another instance in which li-ion battery, s/n (b)(4) was put into the platform on 10/30/2014 and remained in the platform until 10/31/2014.This means that the battery was in the platform for one day before it was removed from the platform.Daily swaps and checks were correctly performed on 11/05/2014 and 11/06/2014.Functional testing was performed and the reported issue was not confirmed.The returned platform passed functional test.A load cell characterization test was performed and the results show that load cell module 1 was under reporting at the fine weight measurement while load cell module 2 was reporting normally.The measurements show that both load cell modules reported normally when both heavy weights were applied.All parameters for returned platform met manufacturer's specifications.Based on the initial investigation, the parts identified for replacement were the load plate cover and the battery partition cover.In summary, the reported complaint of the platform stopping compressions was confirmed based on the archive review but could not be reproduced during functional test.However, the customer's report that there was no audible and visual alarm before the platform stopped compressions was not confirmed based on the archive review.The autopulse archive indicated that the platform triggered the correct visual and audible alarms when the battery reached a low charge state.This was verified through functional testing and evaluation.Investigation into the device and the complaint indicated that the cause of the platform issue was due to user error.The customer received a "low battery" message, which directed them to replace the battery; however, they did not replace the battery when the low battery warning was issued.The physical damages found during visual inspection of the platform are unrelated to the complaint.
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