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 04/04/2024

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (b)(6) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message during the resuscitation of an elderly female patient.As a result, the crew performed manual cpr for the remainder of the call until reaching the hospital.No further information was provided.No consequences or impacts on the patient.

Manufacturer Narrative

The reported complaint of "the autopulse platform (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during functional testing and based on the review of the archive data.The root cause of the (ua) 07 was due to the failed load cell modules.The cracked front enclosure and failed load cells were likely attributed to mishandling, such as a drop.Upon visual inspection, unrelated to the reported complaint, observed a cracked front enclosure, likely attributed to user mishandling, such as a drop.The front enclosure was replaced to remedy the problem.Also, unrelated to the reported complaint, noticed a worn down shaft lock pin and a defective reset switch cable.The observed issues are likely attributed to the device's aging.The autopulse platform was manufactured in 2017 and is more than 6 years old, past the expected service life of 5 years.The shaft lock pin and a defective reset switch cable were replaced to address the issue.In addition, unrelated to the reported complaint, the encoder driveshaft of the platform does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.This type of driveshaft issue is characteristic of the normal use of the platform.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.A review of the archive data showed multiple (ua) 07 error messages to have occurred around the customer's reported event date, thus confirming the reported complaint.The autopulse platform failed the initial functional testing due to the (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.During the power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization test results confirmed that both load cell modules exceeded normal parameters and were replaced to remedy the (ua) 07 error.Following the service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged 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 (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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19198690
• MDR Text Key: 341283736
• Report Number: 3010617000-2024-00353
• 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: 04/26/2024

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: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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