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

Model Number 8700-0752

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint was not confirmed during archive review and initial functional testing.The battery is working as intended for use.No physical damage and four green leds were illuminated when the status button was pressed during visual inspection.During functional testing the battery was tested by inserting into a good known reference autopulse multi chemistry charger (mcc) and was able to successfully charge with the battery illuminating four green leds on the battery status indicating that the battery is fully charged.The battery was tested with known good autopulse platform using the large rtf, performing compressions to specification and passing the functional test without any errors.A review of the battery's archive data indicated that the battery was last charged successfully on (b)(6) 2017 and was last inserted/used in the autopulse by the customer on (b)(6), 2018.The archive data also recorded multiple mcc charging cancellation events from (b)(6) 2018 to (b)(6) 2018.Based on the evaluation, a likely cause for the reported event is attributed to user error.The autopulse power system user guide states that "a test-cycle can take up to 10 hours.Never interrupt a test-cycle by removing the battery from the charger.A battery that initially fails a test-cycle will automatically undergo additional test-cycles.Up to three test-cycles may be performed until the battery is considered to have failed (red led)." historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for li-ion battery sn (b)(4).

Event Description

During product demonstration, the status indicator on the autopulse battery (sn (b)(4)) displayed all green leds; however, when the battery was inserted into the autopulse platform, it did not power on the platform as expected.The battery was tested with another platform without success.Following this, the reporter placed the battery into the multi chemistry charger, but after charging the battery overnight, battery could not power on the platform.There was no patient involvement.

• 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: 7394521
• MDR Text Key: 104543821
• Report Number: 3010617000-2018-00418
• 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: Other
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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: 03/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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