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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During the shift check, the autopulse li-ion battery (sn (b)(6) status leds displayed 4 flashing green lights after it was removed from the multi-chemistry battery charger (mcc).However, the battery was unable to power on the autopulse platform.While the led indicator status on the charger after the charging attempt is unknown, the same issue persisted when the battery was tested with a different charger.The autopulse platform was tested with another battery and functioned as intended.No patient involvement.
Additional Manufacturer Narrative
The customer reported complaint that the autopulse li-ion battery (sn 00355) shows as fully charged on the multi-chemistry battery charger (mcc), but it is unable to power 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 of the reported complaint was a battery-charger communication failure.The archive review indicates that on (b)(6) 2024, the battery remained in the charger for 16 hours without initiating a charge.Upon reinsertion, the conditioning cycle was completed successfully, and the battery charged as expected.This issue was likely caused by a temporary communication error between the battery and the charger, which was resolved after reinserting it into the charger.The archive shows 306 successful charge cycles over the battery's lifetime.The autopulse li-ion battery was successfully charged in a known good autopulse multi-chemistry battery charger.The status leds on the battery showed four flashing green lights.The battery was able to successfully power an autopulse platform until discharged without issue.

• 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: 21077456
• Report Number: 3010617000-2025-00012
• Device Sequence Number: 6916658
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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