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

Model Number 8700-0752

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the zoll li-ion battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Medical safety assessments: 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, autopulse platform stopped performing compressions after only 10 minutes with the second fully charged battery.The crew reverted to manual cpr immediately.During manual cpr, the 3rd battery was installed into the platform and compression was resumed without any delay until time of death communicated.Patient expired after a combination of mechanical and manual cpr.Deployment of the device or changing battery and restart compression can be performed quickly by trained users, the short interruption is similar to the time necessary for rescuer rotation.Therefore, battery exchange for autopulse presents the same workflow as manual cpr in which rescuers are rotated.Hence, the patients' outcome is not negatively impacted by the interruptions when compared to standard of care manual cpr.The cause of patient's death was likely to be cardiac arrest.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).In this event, death is attributed to ohca.Death is an expected outcome for ohca.Please see the following related mfr report: mfr # 3010617000-2018-00259 for autopulse platform with sn: (b)(4) (b)(6).Mfr # 3010617000-2018-00220 the 1st autopulse¿ li-ion battery (b)(6).Mfr # 3010617000-2018-00278 the 2nd autopulse¿ li-ion battery (b)(6).

Event Description

The patient that was experiencing cardiac arrest arrived at the (b)(6) hospital.Thrombolysis was administered upon arrival and at least 60 minutes of manual cpr were performed.The autopulse platform was deployed without any issues and compression were performed between 5-10 minutes and the first battery was completely discharged.A 2nd fully charged li-ion battery was installed and compression resumed without any delay.Ten (10) minutes into the therapy, the platform powered off.The customer then immediately reverted to manual cpr and cath lab was called for 3rd battery.The platform was removed during pulse check under the supervision of the leading register and the 3rd li-ion battery was installed into the platform; however, the platform did not power up.The customer then inserted the 4th li-ion battery and compression was resumed without any delay until time of death communicated.The customer does not attribute the patient death to the use of the autopulse.

Manufacturer Narrative

The li-ion battery sn (b)(4) was returned for evaluation and no issues were found.The battery was received with 3 flashing amber leds.In addition, the battery was disabled by the mcc indicating 3 flashing amber leds.The battery was manufactured in march 2013.Based on the aging of the battery, it is 5 years old and was at end of their service life usage.Patient expired after a combination of mechanical and manual cpr.Deployment of the device or changing battery and restart compression can be performed quickly by trained users, the short interruption is similar to the time necessary for rescuer rotation.Therefore, battery exchange for autopusle presents the same workflow as manual cpr in which rescuers are rotated.Hence, the patients' outcome is not negatively impacted by the interruption when compared to standard of care manual cpr.The cause of patient's death was likely to be cardiac arrest.Please see the following related mfr reports: mfr # (b)(4) 1st autopulse li-ion battery sn (b)(4).Mfr # (b)(4) 2nd autopulse li-ion battery sn (b)(4).Mfr # (b)(4) autopulse platform sn (b)(4).

• 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: 7287782
• MDR Text Key: 100908959
• Report Number: 3010617000-2018-00279
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0