MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the 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.According to multiple studies, out-of-hospital cardiac arrest (ohca) is considered one of the leading causes of death in industrialized nations, with a significant number of deaths occurring outside of a hospital setting, making it a major public health concern; this information is supported by research from the cdc, studies on global mortality rates, and data from various cardiac arrest registries.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 or Problem Description
During the call, the customer reported an issue involving the use of two autopulse platforms on a single patient.The first autopulse platform (sn (b)(6)) indicated the need to reposition the patient, even after multiple adjustments.Upon switching to the second platform (sn (b)(6)), which was a zoll loaner device provided to the customer, the system continued to prompt for lifeband repositioning despite multiple adjustment attempts.Per the reporter, the patient did not survive.No additional information was provided.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, the msa evaluated the incident and it was determined that the death was not related to the autopulse device.
Additional Manufacturer Narrative
The customer reported that the autopulse platform (sn (b)(6) continued to prompt for lifeband repositioning was confirmed in the archive data but not confirmed during functional testing.No device malfunction was observed during the testing, and the autopulse platform functioned as intended.Based on the archive, the platform displayed user advisory (ua) 02 (compression tracking error) error messages around the reported event date.The likely root cause for the reported complaint was due to the patient not being correctly oriented on the autopulse platform, or the patient shifted, which is likely attributed to an unintended user error.A user advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse® 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.A review of the archive data showed that the autopulse platform initially delivered 48 chest compressions.Subsequently, it was switched to pause before being reactivated in start mode.The device then administered an additional 70 compressions before stopping and displaying the ua02 error message, thus confirming the reported complaint.The autopulse platform passed initial functional testing without any fault or error.In addition, the load characterization check was performed and verified that both load cells were functioning within the specification.A brake gap inspection was performed to verify that the brake gap was within the specifications.Following service, the autopulse platform passed 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.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21914455
• Report Number: 3010617000-2025-00296
• Device Sequence Number: 7220393
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown