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

Model Number 8700-0752

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse li-ion battery did not hold a charge.Customer indicated that the battery was rotated to multiple chargers for overnight charging with the same results.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse battery in complaint was returned to zoll on 03/05/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned battery as follows: functional testing confirmed the customer's reported event.The unit was disabled by the test multi-chemistry charger (mcc).The battery's archive data was reviewed and could not confirm that the battery was used on the reported event date of (b)(6) 2015.However, the last recorded date of use was on (b)(6) 2015.Further review of the archive data revealed that the battery was not charged for more than 7 days.The unit was in and out of the charger indicating "conditional cycle cancelled" and never completed conditional cycle and load test.Based on the evaluation, the reported complaint was confirmed and attributed to the customer prematurely removing the battery from the multi-chemistry charger prior to the conditional cycle being completed and the load test passing.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4596816
• MDR Text Key: 5632293
• Report Number: 3010617000-2015-00161
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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