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 Insufficient Information (4580)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

The autopulse nxt platform in the complaint was returned to zoll on 25 january 2024 for evaluation.However, the investigation is still in progress.A follow-up report will be filed when the investigation has been completed.

Event Description

The autopulse nxt platform (sn (b)(6)) was used to resuscitate a patient in cardiac arrest.The patient's clothes were removed, and the patient was placed on the platform with bare skin.The autopulse nxt platform was used on a hardwood floor inside the patient's house living room (~ 60f degrees ambient temperature).The customer used the nxt carry case throughout the entire call.The nxt carry case was first used on a hardwood floor in the residence, and later, it was moved to the cot with a sheet on the mattress.The crew reported that nothing was blocking the nxt platform vents.The nxt platform delivered compressions with the first battery for about 20 minutes, and at that point, the crew noticed a smell described as "burned plastic." the crew kept the nxt platform running regardless of the smell until the platform displayed a low battery alert.The crew proceeded to switch to a second battery.A few minutes (4 to 5 minutes) after the second battery was deployed, the patient call was terminated.The nxt platform did not stop compressions, but the crew stated that the "burned plastic" smell was noticeable as it quickly traveled through the er room.Per the customer, the batteries used during this event have been put into the autopulse nxt charger, and no errors or faults were detected.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

H4 (device manufacture date) was updated.The reported complaint that the autopulse nxt platform (sn 00142) emitted a "burned plastic" smell was not confirmed during functional testing.The autopulse platform functioned as intended.Visual inspection of the returned autopulse platform showed no physical damage.The autopulse platform passed preliminary functional testing without any fault or error.The customer's reported complaint was not replicated, as no "burning smell" was noticed during the initial functional test.As a customer accommodation, zoll replaced this autopulse nxt platform.Therefore, this platform will not be returned to the customer.

• 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: 18682252
• MDR Text Key: 335589722
• Report Number: 3010617000-2024-00109
• Device Sequence Number: 1
• Product Code: DRM
• 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: 03/15/2024

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?: Yes
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 250 KG