MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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 03/25/2024

Event Type  malfunction  

Event Description

During shift check, the autopulse platform (b)(6) displayed a "system error, out of service, revert to manual cpr" message.The customer replaced the battery to troubleshoot the issue, but the system error persisted.No patient involvement.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform (b)(6) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the functional testing and based on the archive data review.The root cause of the reported complaint was the failed processor board (pca), likely attributed to the failed component as the processor board was replaced in (b)(6) 2022.During visual inspection, no physical damage was observed.As part of routine service during testing, the platform was examined, and unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate, likely attributed to wear and tear.The clutch plate was replaced to address the problem.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 "system error, out of service, revert to manual cpr" displayed upon powering up, thus confirming the customer's complaint.The processor pca assembly was replaced to address the system error.Following the service, the autopulse platform passed the run-in test 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 were 4 similar complaints reported for autopulse platform serial number (b)(6).Ccr 19857 was reported on 02 june 2015, ccr 23742 was reported on 02 august 2016, ccr 42351 was reported on 15 october 2018, and ccr 70889 was reported on 28 november 2022, the processor board was replaced to remedy the fault.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: 19149767
• MDR Text Key: 341434848
• Report Number: 3010617000-2024-00320
• 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
• Report Date: 04/19/2024

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
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2012
• 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