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

Model Number 8700-0752

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform (serial number (sn): (b)(4)) displayed a "replace battery" message using 3 autopulse li-ion batteries that were fully charged after a 24 hour rotation.All batteries (sn's: (b)(4)) had this issue once in the platform on different dates in and around (b)(6) 2014.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Customer indicated that this issue occurred at station 32.The autopulse battery in complaint was returned to zoll on 03/06/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Please see the following related mfr.Reports: 1.#3010617000-2015-00172 for autopulse® resuscitation model 100 with sn: (b)(4).2.#3010617000-2015-00174 for autopulse® li-ion battery with sn: (b)(4).3.#3010617000-2015-00175 for autopulse® li-ion battery with sn: (b)(4).

Manufacturer Narrative

Please see the following related mfr.Reports: #3010617000-2015-00172 for autopulse® resuscitation model 100 with sn: (b)(4); #3010617000-2015-00174 for autopulse® li-ion battery with sn: (b)(4), #3010617000-2015-00175 for autopulse® li-ion battery with sn: (b)(4).Investigation results for the returned battery are as follows: please note that the customer also returned autopulse multi-chemistry charger (mcc) with sn (b)(4).Visual inspection of the charger found that one of the pins in the right bay of the charger was pushed in.This led to an intermittent connection between the charger and the batteries inserted into the charger.A review of the charger's and returned battery's archive data was performed and found that li-ion battery with sn: (b)(4) experienced intermittent bouts of charging and not charging, until it was eventually disabled by the charger when it did not pass the performance test in (b)(4) 2014 due to the bad connection with the charger's pin.

• 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: 4639571
• MDR Text Key: 5614396
• Report Number: 3010617000-2015-00173
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• 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: 03/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2012
• 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