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

Model Number 8700-0752

Device Problems Failure to Power Up (1476); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed during archive data review; however, was not reproduced during functional testing of the autopulse lithium-ion battery (sn (b)(4)).A root cause was attributed to battery mismanagement.The battery was received with no physical damage observed and three led illuminated on the battery status indicator during visual inspection.The battery was functionally tested by inserting into a good known reference mcc and was able to successfully charge.After charging, the battery illuminated four green led on the battery status indicator and was able to power up the autopulse platform, thus not confirming the customer complaint.The battery is working to specifications.Review of the retrieved archive data revealed that the battery was last successfully charged in the autopulse multi-chemistry charger (mcc) on (b)(6) 2018.The battery left on the shelf for about 20 days.From (b)(6) 2018, to (b)(6) 2018, battery recorded six (6) more in-out device charging cancellation events and one autopulse platform use for about 4.5 minutes.The battery was left again without charging for about 24 days.On september (b)(6) 2018, the battery recorded charging cancellation event.Apparently, the battery was pulled out on conditioning cycle.The customer inserted the battery in the multi-chemistry charger but pulled it out after few seconds during the conditioning cycle.Immediately the customer re-inserted the battery back into the charger, however, pulled out from the multi-chemistry charger again during the conditioning cycle.On (b)(6) 2018, the customer made another attempt to charge, again it was canceled and pulled out from the multi-chemistry charger before it finishes the charging with no load test.Battery remaining capacity during this period of time is about 871 mah equivalent to three amber lights on the battery status bar.

Event Description

During the battery rotation, the customer indicated the autopulse lithium-ion battery (sn (b)(4)) status indicator displayed full capacity.Prior to placing the battery into the charger, the user tested the battery by placing it in autopulse platform, and the platform displayed a "replace battery" message.The battery was inserted in an autopulse multi-chemistry charger and failed to charge.There was no patient involvement.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8035704
• MDR Text Key: 126303573
• Report Number: 3010617000-2018-01103
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1