MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® NIMH BATTERY

Model Number 8700-0702-01

Device Problems Failure to Charge (1085); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse nimh battery would not power on an autopulse platform.Customer also stated that the battery will not charge in a multi-chemistry charger.However, one green led light is displayed at the end of the battery (indicating that the battery is fully charged and ready for use).No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse battery in complaint was returned to zoll on 06/09/2014 for investigation.The battery was placed in the battery tester, and the results indicated that the battery was below the minimum power output watts of 1300w with a reading of 1028.6w.The battery was then fully charged and test cycled, then re-tested with the battery tester, where the results indicated that the battery was above the minimum power output watts of 1300w with a reading of 1341.1w.An investigation conducted using the battery's serial number found that the battery was within its expected life span of 2-4 years with a manufacture date of 4/2013, and the proper amount of test cycles (10 +/- 1 expected, 10 performed) were performed.The expected service life of the autopulse battery is 100 charge cycles or 2 to 4 years depending on battery maintenance and usage patterns.Both of the customer's reported complaint could not be confirmed as the battery passed testing and was able to power on a platform at zoll.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH 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: 3816783
• MDR Text Key: 4497344
• Report Number: 3003793491-2014-00245
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0702-01
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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