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	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported during shift check, the autopulse li-ion battery (sn (b)(6) will not charge and is no longer powering on the autopulse platform.According to the customer, the battery was pulled off the multi-chemistry battery charger (mcc) but did not power on the platform.The color of the status leds on the battery and charger prior to use in the platform are unknown.After the attempted use in the platform, the status leds on the battery showed one orange led.The battery was tested in a different mcc but it was still unable to charge.The mcc is able to successfully charge other batteries.It is unknown the last time the battery was successfully charged.The platform is performing as intended with other batteries.No patient involvement.
Additional Manufacturer Narrative
The customer complaint that the autopulse li-ion battery (sn (b)(6) will not charge and is no longer powering on the autopulse platform was confirmed during the functional testing.The archive data could not be retrieved, and a review was not performed.Without being able to reset the internal microprocessor and access the archive files, the root cause of the reported battery failure could not be determined through this investigation.However, the probable root cause for the reported complaint could be due to battery mismanagement and charging practice or electrostatic discharge (esd) or broken/damaged components or a battery - charger communication failure.Upon visual inspection, no physical damage was observed, and the status leds of the battery did not illuminate.The battery failed to charge in a known good autopulse multi-chemistry battery charger (mcc).The status leds of the battery did not illuminate after the charging event.The status leds on the mcc showed a red "fail" led indication.Therefore, the battery cannot be used in the autopulse platform.The battery failed to power on the platform, confirming the reported complaint.

• 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: 20467791
• Report Number: 3010617000-2024-00824
• Device Sequence Number: 17980144
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/16/2024

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: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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