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 02/01/2024

Event Type  malfunction  

Event Description

During device check after a patient call, the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).No patient information nor adverse effects were reported.No patient involvement.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during both archive data review and functional testing.The root cause of the ua07 was due to failed load cell #2, likely attributed to the age of the platform, failed components, or mishandling such as a drop.The autopulse platform was manufactured in january 2008 and is over 16 years old, well beyond its expected service life of 5 years.Visual inspection of the returned autopulse platform did not show any apparent physical damage.Further inspection revealed that the encoder driveshaft could not rotate smoothly, unrelated to the reported complaint.The root cause of the observed issue was the worn-out integrated encoder gearbox, likely attributed to the age of the platform.The integrated encoder gearbox was replaced to resolve the problem.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) around the customer's reported event date, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform, confirming the reported complaint.A load cell characterization test was performed and indicated that load cell #2 was over-reporting, and it was replaced to remedy the fault.Following service, another load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18785368
• MDR Text Key: 336417412
• Report Number: 3010617000-2024-00170
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2008
• 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