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

Model Number 8700-0752

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during functional testing of the returned autopulse lithium ion battery.The battery failed charging in a known good multi chemistry charger.No physical damage was observed, and four green lights were lit on incoming inspection.From the battery archive review, battery was last charged successfully on (b)(6) 2018 and was last used/inserted in the autopulse (b)(6) 2018.From (b)(6) 2018 to the end of the archive on (b)(6) 2018, battery recorded multiple repeated cell over-voltage during each customer's charged attempts.Possible cause for the over-voltage can include damaged bleed-resistor, open cell-tab, or voltage-sense resistor on the battery management board.The battery continued to show four green leds on the battery status because it was charged when the problem occurred.

Event Description

During a shift check, the autopulse lithium ion battery failed to charge in the multi chemistry charger and display red x led.Additionally, the battery status indicator displayed as fully charged.The user tested the battery by placing it in autopulse platform, and the platform displayed a "replace battery" message.No patient involvement was reported.

• 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7470901
• MDR Text Key: 106973472
• Report Number: 3010617000-2018-00484
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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