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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
A review of the archive data showed no significant discrepancies or faults.

• 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: 18853068
• Report Number: 3010617000-2024-00205
• Device Sequence Number: 15260591
• Product Code: DRM
• UDI-Device Identifier: 00849111003049
• UDI-Public: 00849111003049
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 04/16/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/12/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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 Sex: Unknown