MAUDE Adverse Event Report: ZOLL CIRCULATION 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 02/09/2024

Event Type  malfunction  

Event Description

The autopulse nxt platform (sn (b)(6)) and fully charged autopulse nxt lithium-ion battery (sn (b)(6)) were used to resuscitate a 180 lbs.Female patient in cardiac arrest.The customer reported that the autopulse nxt platform provided less than 30 minutes of compressions before it displayed a flashing battery low indication (triangle caution) and one light on the battery.The patient event occurred indoors, and the approximate ambient temperature was 70 °f.No consequences or impacts on the patient.

Manufacturer Narrative

Zoll has not received the autopulse nxt lithium-ion battery in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint was not confirmed during functional testing.The autopulse nxt lithium battery functioned as intended.Upon visual inspection, no physical damage was observed.The status leds on the nxt battery showed four steady green lights upon receipt, indicating the battery was fully charged.The nxt battery's archive data did not show any significant anomalies or errors.The nxt battery successfully charged in a known-good nxt battery charger, with four steady green lights lit after charging.The nxt battery was tested in a known-good autopulse nxt platform and successfully powered the platform for 42 minutes total.The customer's reported complaint was not replicated.

• Brand Name: AUTOPULSE NXT LITHIUM-ION BATTERY
• Type of Device: LI-ION BATTERY, RECHARGEABLE
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18853065
• MDR Text Key: 337073739
• Report Number: 3010617000-2024-00206
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• 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