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

Model Number 8700-0752

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery was returned to zoll on 04/09/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During routine testing, the autopulse li-ion battery (sn (b)(4)) reportedly was able to successfully charge in the autopulse multi chemistry charger.The battery was further tested by inserting it in an autopulse platform; however, the platform was unable to power on.No patient involvement.The platform was further tested using another battery and operated as expected with no observed issue.

Manufacturer Narrative

The reported event was not reproduced during functional testing; however, was confirmed through archive data review of the autopulse lithium ion battery (sn (b)(4).No issue was found during functional testing of the battery.The battery was received with no physical damage with four flashing green led illuminated on the battery status indicator.The green flashing leds informs the user that the battery has exceeded its expected service life of 3 years and is fully charged.The autopulse battery is a reusable device and was manufactured on nov 2013, it is approaching its end of life of 5 years.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 was also tested by inserting it in a good known reference autopulse platform using a large resuscitation test fixture.The platform performed continuous compressions for 29 minutes without any issue observed.Review of the retrieved archive data revealed that the battery was last successfully charged in the autopulse multi chemistry charger (mcc) on 06 mar 2018 and was last used on an autopulse platform on 17 mar 2018.On 20 mar 2018, the battery was inserted in an mcc; however, a charging cancellation was recorded 18 seconds into the conditioning cycle.From 24 mar 2018 onwards, events indicating battery insertion in an autopulse platform were recorded.The platform did not power on or was not powered on during these events.This issue is what the user likely experienced on the customer reported event date of 27 mar 2018.The customer reported event is attributed to a user error during mcc charging.When an autopulse li-ion battery was placed in the mcc for charging, additional test cycles ontop of the regular charging cycle may be required to successfully charge the battery.The autopulse power system user guide states that "a test-cycle can take up to 10 hours.Never interrupt a test-cycle by removing the battery from the charger.A battery that initially fails a test-cycle will automatically undergo additional test-cycles.Up to three test-cycles may be performed until the battery is considered to have failed (red led).".

• 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: 7467447
• MDR Text Key: 106883639
• Report Number: 3010617000-2018-00411
• 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: 05/21/2018

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: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1