MAUDE Adverse Event Report: ZOLL CIRCULATION INC. AUTOPULSE® NXT LITHIUM-ION BATTERY; LI-ION BATTERY, RECHARGEABLE

Model Number  NXT BATTERY

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse nxt lithium battery for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Event Description

On (b)(6) the fully charged autopulse nxt lithium battery (b)(6) died after 14 mins during patient use.The crew switched to the lucas device.The autopulse nxt platform is performing as intended with other batteries.No impact or consequence to the patient.

Manufacturer Narrative

(describe event or problem) was updated.The reported complaint of the fully charged autopulse nxt lithium battery (sn (b)(6) died after 14 mins 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 three green lights.The battery archive was downloaded and reviewed with no errors.No issues with current calibration or lifetime cell voltages were observed.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.The battery was tested in a known-good ap nxt platform and successfully powered the platform for an entire 30-minute run.

Event Description

On feb 22, the fully charged autopulse nxt lithium battery (sn (b)(6) died after 14 mins during patient use.The patient was a 49-year-old male who weighed 74.8 kg.The crew switched to the lucas device.The autopulse nxt platform is performing as intended with other batteries.No impact or consequence to the patient.

• Brand Name: AUTOPULSE® NXT LITHIUM-ION BATTERY
• Type of Device: LI-ION BATTERY, RECHARGEABLE
• 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 ; 4084192922
• MDR Report Key: 19006048
• MDR Text Key: 339011043
• Report Number: 3010617000-2024-00327
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NXT BATTERY
• Device Catalogue Number: 8700-001012-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG