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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received autopulse platform for investigation.A supplemental report will be filed when the product is returned, and investigation has been completed.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 (b)(6) was used to resuscitate a patient (50-60-year-old female) in cardiac arrest.Per the reporter, the platform would not start compressions after the green (start) button was pressed multiple times and the lcd screen became pixelated.The crew immediately switched to manual cpr for an unknown time.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead.Per the reporter, the patient's death was not related to the autopulse platform.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6)) would not start compressions was confirmed during the functional testing and the archive data review.Based on the archive review, the autopulse platform displayed fault code 16 (timeout moving to take-up position).The root cause of the reported complaint was a seized brake gap, due to corrosion/rust on the brake housing area of the drivetrain motor, which prevents the brake from opening or closing during activation.This will cause fault code 16 and prevent the platform from performing compressions.Frequent daily device checks and storing the autopulse in a low humidity location could help prevent the brake gap from seizing.The lack of proper maintenance and high relative humidity most likely caused degradation of the mechanical components of the drivetrain to occur, leading to eventual brake seizure.The customer's secondary complaint of the pixelated lcd was confirmed during the functional testing.During the testing, the platform displayed pixelated characters and the screen was not readable.The root cause of this issue was a malfunctioning lcd, likely attributed to failed component(s).Upon visual inspection, no physical damage was observed on the returned autopulse platform.The archive data was reviewed and revealed a fault code 16 around the customer's reported event date, confirming the reported complaint.The platform failed the initial functional testing due to fault code 16; thus, confirming the reported complaint.The autopulse platform did not achieve the target depth for take-up within the specified time (~5 secs) due to the drive train motor having rust or corrosion at the brake assembly area.The brake body was seized from the rust or corrosion and will prevent the brake from opening or closing during activation.Isopropyl alcohol (ipa) was used to clean and remove corrosion at the brake housing area.After the corrosion was removed, the brake gap inspection was performed and verified the brake gap was within specification.During further testing, unrelated to the reported complaint, the platform stopped compressions during the run-in test and displayed a fault code 27 (encoder fault).The root cause of the fault was a power distribution board (pdb) failure.The pdb was replaced to remedy the issue.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries 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 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.

• 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 sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919233
• MDR Text Key: 337854955
• Report Number: 3010617000-2024-00215
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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 Sex: Female