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

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2019

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 for 45 minutes and passed the functional test without any errors.The battery archive was downloaded and reviewed.Battery charging was cancelled by the customer during the conditioning cycle (on (b)(6) 2019).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).".

Event Description

As reported, the autopulse lithium-ion battery (sn (b)(4)) was showing fully charged by pressing on the status button.However, the autopulse platform displayed a low charge when the battery was placed.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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8552987
• MDR Text Key: 143591100
• Report Number: 3010617000-2019-00329
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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