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 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) displayed fault code 27 (encoder fault (> 3000 rpm)) was confirmed during functional testing and review of the archive data.The root cause of the reported complaint was a failure of the integrated encoder gearbox, likely attributed to a failed component.During the visual inspection, no physical damage was observed.A review of the archive data showed multiple fault code 27 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 fault code 27 message displayed after a few compressions, thus confirming the reported complaint.The fault code 27 occurred when the spool drive shaft was turning too fast at a speed higher than 3000 rpm during compression.The defective encoder gearbox was replaced to address the observed failure.Following the service repair, the autopulse platform was subjected to 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.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with sn (b)(6).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).Survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was around 10% for patients of any age (mozaffarian, circulation, 2016; ebiomedicine 2023).Death is an expected outcome for ohca.

Event Description

The autopulse platform (sn (b)(6)) was used to resuscitate a 65-year-old female weighing 110 lbs in cardiac arrest who had a medical history focused on heart issues.The cause of cardiac arrest was suspected to be cardiac in origin.There were no signs of trauma, and the incident occurred at a private residence, witnessed by family members.Bystander cpr was not performed.Upon arrival, the glendale police department administered manual cpr, followed by the fire department.Per the reporter, during the call, the platform would start and stop intermittently for less than 10 seconds and display the fault code 27 (encoder fault (> 3000 rpm)) error message.The crew immediately switched to manual cpr for approximately 40 minutes.A hospital base station er physician pronounced the patient dead at the residence after failing to achieve the return of spontaneous circulation (rosc).The cause of death remained undetermined.Per the reporter, the patient's death was not related to the autopulse platform.

• 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: 19047542
• MDR Text Key: 340124919
• Report Number: 3010617000-2024-00293
• 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: 04/04/2024

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: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 50 KG