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 04/01/2024

Event Type  malfunction  

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.

Event Description

During the shift check, the fully charged autopulse nxt battery (sn 00894) showed no power when it was placed into the autopulse nxt platform.Per the reporter, the battery is in a 3-day rotation cycle (charger to shelf, shelf to unit, unit to charger).All lights were illuminated prior to the batter being placed on the shelf and before placement into the nxt platform.Two other batteries charge normally on the same charger.The problem persisted when the battery was tried on another charger.The platform is functional when used with other batteries.No patient involvement.

Manufacturer Narrative

The customer's reported complaint that the autopulse nxt battery (sn (b)(6)) showed no power when it was placed into the autopulse nxt platform was confirmed during the functional testing and archive review data.The likely root cause of the issue based on the archive information was a defective or weak cell.Upon visual inspection, no physical damage was observed.There were no led lights lit on the incoming inspection.Data from the archive revealed that cell 10 registered a voltage of 2134 mv, falling below the 2500 mv threshold, thus indicating a weakened cell state.Functional testing was performed and the battery failed charging in a known good multi chemistry charger.When the battery is inserted into the charger, it will display active charging and gradually increase the number of green leds on the gas gauge until four are visible.Once completed, the battery goes through a condition cycle, which causes it to show one green led.This cycle continues in the loop.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19183191
• MDR Text Key: 341138621
• Report Number: 3010617000-2024-00346
• 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
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Model Number: NXT BATTERY
• Device Catalogue Number: 8700-001012-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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