MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE LI-ION BATTERY; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The reported complaint that autopulse nxt li-ion battery (b)(6) automatically powers on the device was confirmed during functional testing.The likely root cause of the battery issue is a malfunctioning internal component.Upon visual inspection, no physical damage was observed, and the status leds of the battery showed four green lights.The battery passed charging in a known good nxt battery charger, and the status leds on the battery showed four solid green lights after the successful charging attempt.When the battery was tested in a known-good ap nxt platform, the battery automatically powers the platform upon insertion, thus confirming the reported complaint.A full platform test could not be performed due to battery behavior.
Event or Problem Description
The customer received a new autopulse nxt li-ion battery (b)(6).They charged it upon receipt, according to the ifu.The nxt charger showed the green led.When the battery is placed into the autopulse platform, it automatically powers on the device.They`re unable to power off the platform unless the battery is removed.Sales rep taylor avery was on-site to confirm the issue and reported the same issue.The battery automatically powered on multiple devices once inserted.When a different battery was used, the nxt platform operated normally.This occurred during clinical deployment training via a zoll rep.No patient involvement.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• 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: 20218222
• Report Number: 3010617000-2024-00714
• Device Sequence Number: 7801153
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 09/13/2024

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: MODEL 200
• Device Catalogue Number: 8700-001012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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