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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The nxt li-ion battery in the complaint has been received for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
The autopulse nxt platform was applied to a patient on a vsa call and when the paramedic crew attempted to reinitiate the unit, the fully charged autopulse nxt li-ion battery (sn (b)(6)) in the unit died instantly.They swapped out the battery for a spare battery and were able to continue with the cpr.Rosc was achieved within 30 seconds and maintained until transfer of care (toc) at hsn.Also, the battery won't take a charge, and when you press the charge indicator button no lights appear, it's dead.No impact or consequence to the patient.
Additional Manufacturer Narrative
The reported complaint that the fully charged autopulse nxt li-ion battery (sn (b)(6) died instantly in the autopulse nxt platform and now will not charge was confirmed during functional testing.However, since the archive could not be retrieved, the root cause is undetermined.Upon visual inspection, no physical damage was observed.The status leds of the battery did not illuminate.The archive could not be extracted.The customer reported complaint was confirmed during functional testing.The battery failed charging in a known good nxt charger.The charger displayed a red fault light.No leds were lit on the battery after the charging attempt.

• 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: 21405756
• Report Number: 3010617000-2025-00117
• Device Sequence Number: 8524224
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: MODEL 200
• Device Catalogue Number: 8700-001012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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