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

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

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

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery (sn (b)(4)) was returned to zoll on 14 feb 2019 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During patient use, after approximately 10 minutes of autopulse platform compression the user stopped the platform and re positioned the patient, upon power up of the platform, the autopulse li-ion battery (sn (b)(4)) went dead.Following this, the battery was replaced and continued with the autopulse platform compression with no further issues or error.No known impact or patient consequence.

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).Possible root cause could not be determined.No issue was found during functional testing of the battery.The battery was received with no physical damage and one amber led illuminated on the battery status indicator.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's state of charge was checked and the battery status indicator illuminated four green leds.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 46 minutes without any issue observed.Review of the retrieved archive data, on (b)(6) 2019 (around the date of the reported event), the autopulse battery s/n (b)(4) recorded a momentary over-current error after it was used in the autopulse platform.At the time of this event, the remaining battery capacity was about 457 mah, equivalent to one amber light on the battery status bar.Later on this same day, the customer inserted the battery in the multi-chemistry charger to charge, but the charging cycle was cancelled; the battery was pulled out from the charger too early before it finished the charging cycle.This battery was last successfully charged by the customer on (b)(6) 2019.A root cause for the over-current error could not be determined as the autopulse platform was not returned for investigation.Based on technical investigations of similar devices, a possible cause for this error was that the autopulse lifeband was jammed, momentarily demanding an excessive current, which also caused the battery to discharge more quickly than under standard conditions.

• 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: 8352273
• MDR Text Key: 136856763
• Report Number: 3010617000-2019-00157
• 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: 02/26/2019

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: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1