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

Model Number NXT PLATFORM

Device Problems Use of Device Problem (1670); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The autopulse nxt platform in the complaint was returned to zoll 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 56-year-old male patient (height: 6.2 ft and weight: 300 lbs.) in cardiac arrest.The code was initially run outside on the street ( approximately 20°f ambient temperature at 10:30 pm, very cold outside).The patient's jacket was removed, and the patient's shirt was cut and tucked under his back.The nxt platform was deployed, and when the crew attempted to start compressions, the nxt platform started sizing the patient and then released the band but did not start compressing.The crew continued with manual cpr.When the crew supervisor arrived on the scene, the supervisor checked the band and detected that the nxt lifeband pins were not secured on the spools.The supervisor correctly inserted the nxt lifeband pins into the nxt platform, initiating the compressions.About 20 to 25 minutes into the code, the crew noticed the "plastic burn smell." the patient was then moved from the scene to the ambulance using a ferno stretcher.The nxt platform generated a low battery alert when the crew transported the patient into the ambulance.The crew proceeded to replace the nxt battery.The first nxt battery was noticed to be warmed when the crew switched to the second nxt battery.The crew mentioned that the smell got worse when the first nxt battery was replaced with the second nxt battery.The nxt platform continued compressing with the second nxt battery for about 4 minutes and then stopped compressing and shut off.The crew started manual cpr.When the nxt platform shut down, the crew mentioned that the second nxt battery had 2 bars left on the charge status.The crew mentioned that the nxt platform was also hot to the hand's touch.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

The reported complaint that the autopulse nxt platform (sn 00149) emitted a "plastic burn smell," stopped compressing and shut off was not confirmed during functional testing.The autopulse 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 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: 18699774
• MDR Text Key: 336407039
• Report Number: 3010617000-2024-00119
• 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

• Date FDA Received: 02/13/2024
• 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: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 300 KG