MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2023

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (sn (b)(6)) stopped after performing a few compressions and displayed an error message.The customer couldn't recall the exact error message.The customer also reported that the platform's display screen went black.The customer turned off the autopulse platform and powered it back on, but the display screen was still black.To further troubleshoot the issue, the customer changed batteries.But the problem was not resolved.Per the customer, the autopulse platform was tested again later, but the reported complaint was not replicated.The customer did not provide any further information.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) stopped after performing a few compressions and displayed an error message was confirmed in the archive data review.The platform's archive revealed several incidents where the autopulse platform had stopped compressions due to user advisory (ua) 17 (max motor on-time exceeded during active operation) on the customer's reported event date.The observed ua17 advisory was not replicated during functional testing.Further inspection revealed that the drivetrain motor brake gap was too narrow (out of the specification), triggering the intermittent occurrences of the ua17 advisory message.The customer's secondary reported problem that the autopulse platform's display screen went black was not confirmed during functional testing at zoll.When the platform was powered on, the lcd screen lit up and was fully functional.During visual inspection, no physical damage was observed on the returned autopulse platform.Further review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) also occurred on the reported event, unrelated to the customer's reported complaint.Based on the archive data, the autopulse was powered off and on multiple times, and the platform displayed ua07 each time.The archive shows that the customer cleared the ua07 advisory messages.The likely root cause for this advisory message was either due to the patient, test manikin or the platform being placed on an uneven surface, or not being properly centered or aligned on the platform during operation.User advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 is an indication that the patient or manikin is out of position, or not properly centered on the weight detecting sensors.The recommended actions to take for this type of user advisory are: ensure the patient or manikin is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, press restart to clear the ua.The autopulse platform passed the initial functional test without any fault or error, and the customer's reported complaint could not be replicated.The too-narrow (out of the specification) drivetrain motor brake gap was adjusted within the specification to address the intermittent occurrences of the ua17 advisory messages, which were verified to have occurred during the customer's reported event date.Additionally, the platform's driveshaft was not rotating smoothly due to having a sticky clutch plate, unrelated to the reported complaint.The sticky driveshaft clutch area is usually caused by sharp edges or burrs on the surface of the clutch rotor, likely due to wear and tear.The autopulse platform was manufactured in march 2018 and is almost 6 years old and has exceeded its expected service life of 5 years.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to address the issue.Following service, the autopulse platform was subjected to run-in tests 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 was no previous history of 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: 18681474
• MDR Text Key: 335205395
• Report Number: 3010617000-2024-00114
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

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: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• 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