During the patient call, the autopulse platform (sn (b)(4)) did not power on when the autopulse li-ion battery (sn unknown) was used.The crew immediately revert to manual cpr.The return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced deceased.The customer provided no further information.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, the msa evaluate the incident and it was determined that the death was not related to the autopulse device.Per the customer, the autopulse li-ion battery (sn unknown) used in this reported event was not properly charged due to a faulty charger.Please see the following related mfr reports: mfr 3010617000-2022-00386 for autopulse li-ion battery.
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Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.According to available information, the death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.
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