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

Model Number	NXT PLATFORM
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse nxt platform (sn (b)(6) displayed a flashing yellow triangle alert during a training session.The customer paused the nxt platform and compressions stopped.After resuming the nxt platform, the yellow triangle alert flashed again.The customer stated they probably turned off the nxt platform three times and removed the nxt battery, but the issue persisted.No patient involvement.
Additional Manufacturer Narrative
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.A review of the archive data showed no hardware faults.However, software-related fault 1097 was logged for the motor encoder.Fault 1097 is failed to read the encoder position during the sync operation.This fault occurred for 6 consecutive power-ups, lasting about 7 minutes each time.This fault occurs infrequently and causes the yellow triangle indicator to flash.The fault cleared on its own after a total of 38 minutes.The root cause of the fault is unknown.The autopulse nxt platform passed preliminary functional testing without any fault or error.The autopulse nxt platform was tested using the medium resuscitation test fixture (mrtf) with two known-good nxt batteries until discharged without fault or error, and the customer's reported complaint was not replicated.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19226594
• Report Number: 3010617000-2024-00363
• Device Sequence Number: 15363748
• Product Code: DRM
• UDI-Device Identifier: 00849111003049
• UDI-Public: 00849111003049
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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