MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery was returned to zoll on 24 apr 2019 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.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.In this case, when the autopulse platform (sn (b)(4)) used on an (b)(6), average size female in cardiac arrest, it was operating compressions for 15 minutes until the battery was changed due to a low battery condition showed.After the battery change, the unit stopped compressions several times after one or two compressions with no error message was displayed.The crew reverted to manual cpr immediately, however, a return of spontaneous circulation (rosc) was not achieved and the patient was pronounced deceased.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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.

Event Description

As reported, the autopulse platform (sn (b)(4)) was used on a cardiac arrest patient with continuous compression for approximately 15 minutes.The platform's user control panel started to flicker and shortly showed a low battery message.The autopulse battery (sn (b)(4)) used originally showed 3/4 full.Following this, the crew replaced the battery and the platform would stop compression several times after one or two compressions, no error message was displayed.Following this the crew immediately performed manual cpr for 15 minutes.A return of spontaneous circulation (rosc) was not achieved.The patient was pronounced deceased.According to the user, the autopulse platform did not attribute to the patients death.Reference mfr 3010617000-2019-00426 for autopulse platform (sn (b)(4)).

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4) stopping compression was not confirmed during functional testing and battery archive review.No issue was found during functional testing of the autopulse li-ion battery (sn (b)(4).The battery was received with no physical damage and no led illuminated on the battery status indicator.The battery was inserted into a good known reference autopulse multi chemistry charger (mcc) and after completing the charging and testing cycle, the mcc illuminated the green charger led indicating that the mcc was able successfully charge the battery.The battery's state of charge was checked and the battery status indicator illuminated four green leds.The battery was tested by inserting it in a good known reference autopulse platform using a large resuscitation test fixture.The platform performed continuous compressions for 49 minutes without any issue observed.The battery was also tested with the autopulse platform (sn 34702) using a large resuscitation test fixture.The platform performed continuous compressions until discharged without any fault or error observed.The battery archive was downloaded and reviewed, there were no errors recorded during the reported event date however, on (b)(6) 2019 (after the event date), the customer let the battery remains in the platform for an extended period of time and was discharged below its minimum operating voltage.The autopulse power system user guide states that "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery." a fully charged autopulse lithium ion battery left in a zoll autopulse platform for an extended period of time will eventually discharge below its minimum operating voltage.A fully discharged battery will not be able to charge in the mcc.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.In this case, when the autopulse platform (sn 34702) used on an 80 year old, average size female in cardiac arrest, it was operating compressions for 15 minutes until the battery was changed due to a low battery condition showed.After the battery change, the unit stopped compressions several times after one or two compressions with no error message was displayed.The crew reverted to manual cpr immediately, however, a return of spontaneous circulation (rosc) was not achieved and the patient was pronounced deceased.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8589233
• MDR Text Key: 144607237
• Report Number: 3010617000-2019-00427
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: D163369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR