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	10/17/2024
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 not been returned for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported during patient use, the autopulse nxt li-ion batteries (sn (b)(6) only lasted 20 minutes and then got a fault code of 1160.The crew switched to manual cpr.It is unknown which battery was used first.Previous to use in the autopulse nxt platform, the batteries were checked during morning truck checks, and the status leds on the batteries indicated they were fully charged.No impact or consequence to the patient.
Additional Manufacturer Narrative
The reported complaint that the autopulse nxt li-ion battery (sn (b)(6)) only lasted 20 minutes was not confirmed during functional testing or archive data review.No device malfunction was observed during testing, and the battery functioned as intended.Upon visual inspection, no physical damage was observed, and the status leds of the battery showed four green leds.No errors were found in the battery archive.The battery passed charging in a known good nxt charger, and the status leds on the battery showed four steady green lights after the successful charging attempt.The customer complaint could not be replicated.The battery was tested in a known-good ap nxt platform and successfully powered the platform for an entire 30-minute run.

• 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: 20654045
• Report Number: 3010617000-2024-00932
• Device Sequence Number: 17835880
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 12/26/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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