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

Model Number 8700-0752

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

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 was observed and two amber lights were lit on incoming 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 for 30 minutes with known good autopulse platform using the large rtf, performing compressions to specification and passing the functional test without any errors.The battery archive was downloaded and reviewed.There were no errors recorded in the archive, thus not confirming the customer complaint.

Event Description

During patient use on (b)(6) years old male patient in cardiac arrest, it was reported that the autopulse lithium-ion battery (sn (b)(4)) that was used at the time of event worked for only 5 minutes.The crew switched to the manual cpr while the battery was replaced.The second battery was used and the platform was performing compressions as expected.No patient harm or consequences reported on this event.

• 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: 8188050
• MDR Text Key: 131302932
• Report Number: 3010617000-2018-01276
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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
• Patient Age: 59 YR