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

Model Number 8700-0702

Device Problem Premature Discharge of Battery (1057)

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

Event Type  malfunction  

Event Description

It was reported that the autopulse nimh battery did not last very long (less than 15 minutes).There is no specific event information.No adverse patient seqelae was reported.No further information was provided.

Manufacturer Narrative

Customer indicated that their batteries are rotated daily.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 in complaint was returned to zoll on 07/29/2014 for investigation.Investigation results as follows: 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 779.4w.The battery was then fully charged and test cycled, then re-tested with the battery tester, where the results indicated that the battery was below the minimum power output watts of 1300w with a reading of 809.5w.An investigation conducted using the battery's serial number (sn) found that the battery was at the end of its expected life span of 2-4 years with a manufacture date of september 2010.It was also found that the proper amount of test cycles (47 +/- 1 expected, 5 performed) were not performed.The expected service life of the autopulse battery is 100 charge cycles or 2 to 4 years depending on battery maintenance (charged/test cycled as instructed per the ifu) and usage patterns.

• 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: 3939786
• MDR Text Key: 15358791
• Report Number: 3003793491-2014-00351
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0702
• Device Catalogue Number: 8700-0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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