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	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The customer's reported complaint that the autopulse nxt lithium-ion battery (sn (b)(6) exhibited a low operational runtime was not confirmed during functional testing or archive data review.No device malfunction was observed during testing, and the nxt battery functioned as intended.Upon visual inspection, no physical damage was observed, and the battery's status leds showed four green leds, indicating a full charge.The nxt battery's archive data didn't show any significant anomalies or errors.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 returned nxt battery was tested in a known-good nxt platform and successfully powered the platform and ran for 42 minutes.The customer's reported complaint was not replicated.
Event or Problem Description
Patient 1 of 2.During the call, a 44-year-old male patient (approximately 320 lbs) experienced shockable rhythms and was placed on the autopulse nxt platform (sn (b)(6) upstairs to perform chest compressions while being transported to the first floor, where the gurney was positioned.Before movement, it was observed that the nxt platform was not delivering compressions as forcefully as expected.The nxt platform was stopped, and manual compressions were initiated while verifying that the nxt bands were properly positioned without twists or damage.Upon restarting, the nxt platform continued to provide inadequate compressions, despite the nxt bands being correctly placed over the patient's chest.The nxt platform was stopped again, the nxt bands were fully extended, and another inspection was conducted, revealing no apparent issues.After stretching the nxt bands, the nxt platform began to function more effectively, with the monitor detecting proper compressions.However, the nxt platform unexpectedly stopped while in continuous mode and required manual restarting.Upon reaching the first floor, the nxt platform again ceased operation and had to be restarted, despite the patient remaining still.Before loading the patient into the ambulance, the nxt battery (sn (b)(6) was checked and showed a full charge (4 bars).The nxt platform functioned continuously except during rhythm and pulse checks; however, within five minutes, the battery level dropped to three bars, then to half, and shortly thereafter to one bar, at which point the device ceased functioning entirely.Per the reporter, no spare battery was available, requiring manual compressions for the majority of transport to the hospital.No consequences or impact to the patient.Per the reporter, the nxt platform was tested with the new battery later that day and again the following day and appeared to work correctly.

• 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: 21759109
• Report Number: 3010617000-2025-00237
• Device Sequence Number: 15633490
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/02/2025

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: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 145 KG