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

Model Number 8700-0752-01

Device Problem Charging Problem (2892)

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

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Complainant alleged that 14 batteries were unable to hold a charge.No adverse patient sequelae was reported.Customer was unable to provide any additional details.

Manufacturer Narrative

Zoll has not yet received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Please see the following related mfr reports: 3010617000-2014-00555 autopulse li-ion battery with sn unk; 3010617000-2014-00556 autopulse li-ion battery with sn unk; 3010617000-2014-00557 autopulse li-ion battery with sn unk; 3010617000-2014-00558 autopulse li-ion battery with sn unk; 3010617000-2014-00559 autopulse li-ion battery with sn unk; 3010617000-2014-00560 autopulse li-ion battery with sn unk; 3010617000-2014-00562 autopulse li-ion battery with sn unk; 3010617000-2014-00563 autopulse li-ion battery with sn unk; 3010617000-2014-00564 autopulse li-ion battery with sn unk; 3010617000-2014-00565 autopulse li-ion battery with sn unk; 3010617000-2014-00566 autopulse li-ion battery with sn unk; 3010617000-2014-00567 autopulse li-ion battery with sn unk; 3010617000-2014-00568 autopulse li-ion battery with sn unk.

Manufacturer Narrative

Please note that serial # was updated.

• 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: 4208164
• MDR Text Key: 5041016
• Report Number: 3010617000-2014-00561
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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