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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaints that the autopulse platform sn (b)(6) is working intermittently and the display is not functional were not confirmed in the archive data or during functional testing.No device malfunction was found during testing, and the autopulse platform functioned as intended.Visual inspection of the returned autopulse platform revealed some issues unrelated to the customer's reported complaint.The front enclosure was broken at the front-end area.The load plate cover was damaged with a hole, affecting the watertight seal.The observed physical damages are attributed to user mishandling.The front enclosure and load plate cover were replaced to address the issues.Archive data review revealed that there was no active operation recorded on the customer's reported event.Based on the archive data, the autopulse platform was last used in active operation on (b)(6) 2023.On this date, there were no significant discrepancies recorded in the archive.The autopulse platform passed the initial functional test without any fault or error.The lcd backlight was functional, without flickering or missing pixels, and it responded appropriately to the ui membrane buttons.The platform was tested with the large resuscitation test fixture (lrtf) using known-good test batteries, and it functioned appropriately without fault or error.Despite intensive testing, the reported issues of intermittent functionality and display problems could not be reproduced.During open case inspection, the front and bottom enclosures were removed, and fluid ingress was found inside the autopulse platform.The customer stated that the patient aspirated heavily.The patient's body fluid possibly entered the platform, or during the cleaning of the device after the patient call, the fluid ingress occurred.The liquid had contaminated the interior of the device.The autopulse platform was bio-cleaned to address the issue.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.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 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, the 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 reported that the patient aspirated heavily, and the platform stopped working.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead.The customer did not provide any further details regarding the cardiac arrest event.The customer did not provide information regarding the relationship between the death and the alleged device 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.After the call, the crew cleaned up the bodily fluids and did a hard reset of the platform.The autopulse platform worked for a little while.However, the platform is working intermittently, and the display is not functioning as intended.

• 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: 18332380
• MDR Text Key: 330546823
• Report Number: 3010617000-2023-01044
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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