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

Model Number	NXT PLATFORM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010617000-2024-00109
• Device Sequence Number: 6195699
• Product Code: DRM
• UDI-Device Identifier: 00849111003049
• UDI-Public: 00849111003049
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K221700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 250 KG