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

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

The li-ion battery (s/n (b)(4)) was returned for investigation to zoll.Battery was received with no physical damage noted upon receipt.Archive review showed battery generated one error 08 -t mismatch >30°c recorded on (b)(6) 2016 and multiple charge cancellation events from (b)(6) 2016 to the end of the archive on (b)(6) 2016 including multiple battery in and out events.Archive also showed battery was last charged successfully on (b)(6) 2016 and was last inserted into the autopulse on (b)(6) 2016.Functional testing was performed by inserting into a good known multi chemistry charger and battery failed the charging.Battery was also tested from a good known autopulse and battery did not power up the autopulse after pressing the power button.Additional testing was also performed by inserting the battery into the battery tester with hyperterminal and no output from the hyperterminal window after pressing the test button.The customer complaint was confirmed during the functional testing and archive review.The exact root cause of the problem could not be determined however, the most probable cause of the issue could be due to an internal battery fault.The battery manufacturing date is 2016-05-04.

Event Description

It was reported that the battery status led shows a full charge, however it will not power up an autopulse platform.The customer installed another battery and the autopulse platform powered up fine.The failure was observed during a shift check.Battery did not run through the mcc charger to perform further complete testing.Customer also indicated that the battery goes into charger every three days and it is rotated as day 1 (battery placed in the case as the spare battery), day 2 (battery is changed to the autopulse) and day 3 (battery is placed in the charger).As indicated by the customer, this battery when installed full charge,the autopulse platform did not power up.The autopulse powered up when another battery was installed.There were no patient involvement reported on this issue.

• 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: 6211160
• MDR Text Key: 63480072
• Report Number: 3010617000-2016-00954
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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