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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received autopulse platform for investigation.A supplemental report will be filed when the product is returned, and investigation has been completed.

Event Description

The autopulse platform sn (b)(6) displayed a "system error, out of service, revert to manual cpr" error message upon powering up at the beginning of the resuscitation of a cardiac arrest patient.The manual cpr was performed while retrieving another device.No consequences or impact to the patient.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" was confirmed during functional testing and archive data review.The root cause of the reported issue was the processor board (pca) failure, likely due to failed component(s).During visual inspection, the platform was examined, and found to have a cracked front enclosure, unrelated to the reported complaint.This type of physical damage found during visual inspection is characteristic of user mishandling, such as a drop.The front enclosure was replaced to address the physical damage.The archive data review indicated system error 132 (internal watchdog timeout), thus confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device, confirming the reported complaint.The processor board was replaced to address the reported complaint.In addition, unrelated to the reported complaint, the brake gap inspection revealed that the brake gap was out of specification (too wide), measured at 0.012", out of the specification (0.008" ± 0.001").The probable root cause of this issue is due to wear and tear.The brake gap was adjusted to specification to remedy the issue.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19047541
• MDR Text Key: 339435741
• Report Number: 3010617000-2024-00303
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• 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: 05/07/2024

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: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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