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 Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) kept displaying user advisory (ua) 02 (compression tracking error) was confirmed in the archive data but was not confirmed during functional testing.Visual inspection of the returned autopulse platform showed no physical damage.During the visual brake gap inspection, it was observed that the drivetrain motor brake gap was too wide, out of specification.This issue is unrelated to the reported complaint and is most likely attributed to wear and tear.The autopulse platform was manufactured in september 2018 and has exceeded its expected service life of 5 years.The brake gap needs to be adjusted to remedy the problem.The archive data review showed multiple ua02 advisory messages around the reported event date, confirming the reported complaint.Based on the archive data, the ua02 advisor messages were cleared.The archive also showed multiple user advisory (ua) 17 (max motor on-time exceeded during active operation) around the reported event date, unrelated to the reported complaint.The noted ua17 advisory message was reproduced during functional testing.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 battery hangtag - advisory codes description and action, user advisory 02 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.The autopulse platform passed the preliminary functional testing without fault or error, and the customer's reported complaint of ua02 was not replicated.During further testing using the large resuscitation test fixture (lrtf), the platform stopped compressions due to ua17 advisory messages, unrelated to the reported complaint.The root cause of the ua17 was the drivetrain motor brake gap being too wide, out of specification.The adjustment of the brake gap will remedy the fault.Zoll is awaiting the customer's approval for repair.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

Event Description

The autopulse platform (sn (b)(6) was used in an attempt to resuscitate a patient in cardiac arrest.The customer stated that although the lifeband had been correctly installed, it would repeatedly get stuck, and the platform kept displaying user advisory (ua) 02 (compression tracking error).The crew re-adjusted the lifeband, but the issue would reoccur approximately every 30 seconds.After about 10 minutes of trying to use the platform for compressions, the crew stopped using the autopulse and switched to manual cpr for about 50 minutes.Return of spontaneous circulation (rosc) was not achieved, and the patient was later pronounced dead.No further information was provided regarding the details of the cardiac arrest event.The customer did not provide information regarding the relationship between the death and the alleged malfunction.Zoll's medical safety assessment (msa) team evaluated the incident, and it was determined that the death was not related to the autopulse device.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18995937
• MDR Text Key: 339030749
• Report Number: 3010617000-2024-00252
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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