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

Model Number 8700-0752

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the zoll autopulse lithium ion battery in complaint for investigation.A supplemental report will be filed when the 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, the autopulse lithium ion battery failed to power up the platform in sudden cardiac arrest patient.The same result occurred with the spare battery as well.The crew reverted to manual cpr for an unspecified amount of time.The patient did not survived after received manual cpr and was pronounced deceased at hospital.No compression was provided by the autopulse.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.Autopulse did not provide compressions, and did not cause or contribute to the patient's death.In this event, death is attributed to out-of-hospital cardiac arrest (ohca).Death is an expected outcome for ohca.

Event Description

It was reported that the autopulse lithium ion battery (sn (b)(4)) was placed in the autopulse platform for patient use.The battery failed to power up the platform.According to the reporter, the same result occurred after the responding crew inserted the spare battery (sn (b)(4)) into the platform.Ultimately, the crew reverted to manual cpr for an unspecified amount of time.Patient was pronounced deceased at hospital.The reporter indicated the autopulse platform was later tested at the station by zoll sales representative utilizing demo battery.The battery successfully powered on the autopulse platform.According to the reporter, both batteries failed to charge when placed inside the autopulse multi chemistry charger.This complaint is for autopulse lithium ion battery (sn (b)(4)).For event occurred with autopulse lithium ion battery (sn (b)(4)), mfr 3010617000-2018-00348.

Manufacturer Narrative

The reported complaint was confirmed during archive review and functional testing.The archive review showed the battery failed to charge due to improper battery management.No physical damage was observed, and one amber light was lit on incoming inspection.Based on archive review, the customer repeatedly left battery in autopulse platform between uses up to 14 days without charging.Battery remains in the autopulse multiple times and was discharged below its minimum operating voltage which causes the battery cells unhealthy and failed the charging.During the reported event, the customer used / inserted the battery in the autopulse without successfully charging the battery first and caused the battery failed to power up the autopulse.The autopulse power system user guide states: "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 li-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 display any led status lights and will fail charging.

• 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: 7394520
• MDR Text Key: 104539622
• Report Number: 3010617000-2018-00347
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• 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: 03/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR