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

Model Number 8700-0752

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint was not confirmed during archive review and functional testing.The battery has passed all the testing.The battery has exceeded its service life of three years from its date of manufacture; nonetheless, it is fully charged and working as intended for use.No physical damage was observed during visual inspection and three amber leds were illuminated when received.The archive data review indicated that there were no errors recorded from (b)(6) 2017 to the end of the archive on (b)(6) 2018.The battery was last charge successfully on (b)(6) 2018 and was last inserted into the autopulse platform on (b)(6) 2018.During functional testing the battery was inserted into a good known reference multi-chemistry charger (mcc) and the battery passed the charging with four green leds.The battery was also inserted into a good known autopulse platform and passed the testing without any issues.

Event Description

During device check, the li-ion battery (sn: (b)(4)) was inserted into the autopulse platform and only performed 2 minutes of compression.When the status button was pressed on the battery, four green flashing leds were displayed.The battery was not charging when placed into the multi-chemistry charger (mcc).No patient was involved.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7342334
• MDR Text Key: 102599539
• Report Number: 3010617000-2018-00269
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2013
• 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