MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE NXT PLATFORM; CARDIAC CHEST COMPRESSOR

Model Number NXT PLATFORM

Device Problem Use of Device Problem (1670)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse nxt platform 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

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

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint was not confirmed during functional testing.The autopulse nxt platform functioned as intended.Visual inspection of the returned autopulse nxt platform showed no physical damage.The autopulse nxt platform passed preliminary functional testing without any fault or error.The nxt platform was tested using a regular-size manikin and ran for 31 minutes without any error or fault, and the customer's reported complaint was not replicated.

Manufacturer Narrative

A review of the archive data showed no significant discrepancies or faults.

• Brand Name: AUTOPULSE NXT PLATFORM
• Type of Device: CARDIAC CHEST COMPRESSOR
• 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: 18853068
• MDR Text Key: 337074102
• Report Number: 3010617000-2024-00205
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111003049
• UDI-Public: 00849111003049
• 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,Followup
• Report Date: 05/08/2024

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 PLATFORM
• Device Catalogue Number: 8700-001070-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/26/2024; 04/16/2024
• Supplement Dates FDA Received: 04/12/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• 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