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 Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse li-ion battery ((b)(4)) for evaluation.A supplemental report will be filed if and when the battery is returned and investigation has been completed.

Event Description

The customer reported that a fully charged autopulse li-ion battery ((b)(4)) was inserted in the autopulse platform and the platform displayed a replace battery message.The battery were tested using multiple platforms and displayed the replace battery message during all insertions.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.

Manufacturer Narrative

The reported event was unable to be reproduced during functional testing; however, was confirmed through archive data review of the autopulse lithium ion battery (sn (b)(4).The root cause is due to improper battery charging (user error).No issue was found during functional testing of the battery.The battery was received with no physical damage and three amber lights were lit on incoming inspection.The battery was inserted into a good known reference autopulse multi chemistry charger (mcc) and after completing the charging and testing cycle.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 51 minutes without any issue observed.Review of the retrieved archive data revealed, on (b)(6) 2018, the customer inserted the battery into the mcc but was cancelled during the conditioning cycle.On (b)(6) 2018, the battery was inserted in the autopulse platform without successfully charging the battery.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 on top 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: 7563550
• MDR Text Key: 109887919
• Report Number: 3010617000-2018-00594
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 05/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1