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

Model Number 8700-0752-01

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that the battery in the autopulse platform indicated 1 bar on the battery charge icon so it was replaced with an autopulse li-ion battery (sn: (b)(4)) that had been charged.When this battery was inserted into the autopulse platform, the battery charge icon displayed 4 bars (indicating a fully charged battery).However, when the "start/continue" button was pressed, the autopulse platform did not do anything.Customer reinserted the first battery and the autopulse was able to function properly.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse battery was returned to zoll (b)(4) on 07/16/2014 for investigation.Investigation results as follow: initial power readings from the battery were within specification at 1680.2 watts.Although the battery was displaying 4 green leds, it did not power on a test autopulse when inserted into the platform.The battery was also placed into a test multi-chemistry charger but no led lights were displayed.Then, all of the charger's bay lights began to flash.The battery would not successfully charge.Based on the evaluation, the reported complaint of the battery not powering on the autopulse was confirmed.The battery was found to not be functioning properly; however, a definitive cause could not be determined.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3929763
• MDR Text Key: 4671174
• Report Number: 3003793491-2014-00329
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2013
• 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