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 01/16/2024

Event Type  malfunction  

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.The platform's archive data could not be downloaded, however, the apvision3 software confirmed a system error 136 (internal parameter corrupted).The root cause of the system error was the processor board (pca) failure, likely due to the age of the device.The autopulse platform was manufactured in september 2007 and is 16 years old, well beyond its expected service life of 5 years.During visual inspection, unrelated to the reported complaint, the front and bottom enclosures were observed cracked.The observed physical damages appeared to be characteristic of user mishandling.The front and bottom enclosures need to be replaced to address the observed physical damages.Unable to recover data archive due to failed processor board.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the customer complaint.The failed processor board needs to be replaced to remedy the system error.Waiting for customer approval for repair.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 sn(b)(6).

Event Description

During the shift check, the autopulse platform (sn (b)(6)) displayed a 'system error, out of service, revert to manual cpr' error message".No patient involvement.

Manufacturer Narrative

Section h11.Additional investigation findings.Additional issues were observed during service on (b)(6) 2024, unrelated to the reported complaint.Observed multiple top cover's screw bosses were cracked.The top cover was replaced to address the observed physical damage.In addition, the load cell module 2 did not respond to the load being applied.The damaged enclosures and failed load cell were likely attributed to mishandling such as a drop.The defective load cell module 2 was replaced 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.

• 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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18664401
• MDR Text Key: 334838877
• Report Number: 3010617000-2024-00112
• Device Sequence Number: 1
• Product Code: DRM
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2007
• 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