MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY¿; SECONDARY BATTERY

Model Number	100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse li-ion battery (sn (b)(6) had failed during use on the autopulse platform was confirmed during the archive data review but not during functional testing.No device malfunction was observed during testing, and the battery functioned as intended.Based on the archive data review, the possible root cause for the reported complaint was due to an intermittent battery issue caused by an esd (electrostatic discharge) hit at the time of the event.The archive data indicated that on december 14, 2023, the battery encountered an oz deadman error due to esd but recovered after a conditioning cycle.On march 3, 2024, the battery encountered fcc below min and oz deadman errors.The battery did not have a chance to recover due to being pulled from the charger mid-condition cycle.The archive shows 8 successful charge cycles over the battery lifetime.Following a conditioning cycle, the battery passed charging in a known good autopulse multi-chemistry battery charger (mcc), and the status leds on the battery showed four solid green lights after the successful charging attempt.The battery was able to successfully power an autopulse platform until discharged without issue.
Event or Problem Description
The customer reported the autopulse li-ion battery (sn (b)(6) is unable to charge in the multi-chemistry battery charger (mcc).However, based on additional information received from the customer on 12/10/2024, the autopulse platform failed during the patient call when the battery (sn (b)(6) was used.The user switched to the second battery to continue the resuscitation.The patient's status information was requested, but the customer did not provide a response.Per the reporter, the battery was able to charge in multiple chargers, and alternatively, the charger could charge other batteries.

• Brand Name: AUTOPULSE LI-ION BATTERY¿
• Common Device Name: SECONDARY BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 21075862
• Report Number: 3010617000-2025-00004
• Device Sequence Number: 15147071
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown