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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and 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 customer reported the autopulse platform (sn (b)(4)) stopped compressions multiple times during a cardiac arrest event.The device initially worked fine, the crew had to lift up the lifeband and reset it a few times, but the platform and lifeband performed as intended.Then, without warning or displaying any error messages, the platform shut off while operating during normal function.Manual cpr was performed during troubleshooting.The crew tried three different autopulse li-ion batteries, but the same issue occurred.The crew continued manual cpr for the rest of the call.The batteries were showing as fully charged before inserting into the platform and when the batteries were switched out, the batteries still showed as fully charged.The batteries performed as intended in other platforms.The patient was already in cardiac arrest when the crew arrived.Rosc was never achieved.The crew pronounced the patient at the scene of the call.No other patient information is available.The customer reported the platform failure caused a delay and could have caused impact on the patient's survival.However, the msa evaluated the incident, and it was determined that the death was not related to the autopulse device.

Manufacturer Narrative

The customer reported complaint that "the autopulse platform (sn (b)(6)) stopped compressions and shuts off" was confirmed during the archive data review but not during functional testing.A review of the archive file indicated the occurrences of user advisory (ua) 28 (loss of clutch connectivity) error messages on the event date.The clutch controller detected an electrical fault in the clutch when the clutch is energized, causing the platform to shut off.The probable root cause of the reported complaint was due to the drivetrain motor failure, likely attributed to failed component(s).During visual inspection, the front cover was observed to be cracked in the front-end area, unrelated to the reported complaint.The observed physical damages appeared to be the characteristics of harsh impacts due to user mishandling.The front cover will be replaced to address the issue.The power distribution board revision is up to date.Archive data review showed multiple occurrences of (ua) 28 on the event date, which caused the platform to shut off, thus, confirming the reported complaint.The autopulse platform passed initial functional testing without any fault or error.(ua) 28 was not reproduced during functional testing.However, during the run_in test, the platform stopped compressions due to "system error, out of service, revert to manual cpr" error message, unrelated to the customer's reported complaint.The archive indicated the system error message was a system error-139 (unable to hold compression position).The brake was unable to hold the compression position.The drive train motor brake gap was too wide (measured 0.011" out of specification of 0.008" ± 0.001") and cannot be adjusted back into spec.The drivetrain motor was replaced to remedy the system error-139 and (ua) 28, and to perform further testing.Upon replacement, the platform was tested using the large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The load cell characterization test indicated both load cell modules function within the specification.After multiple run_in tests, the drivetrain motor brake gap was inspected and verified to be within the specification of 0.008" ±0.001".Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• 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: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16157862
• MDR Text Key: 307574777
• Report Number: 3010617000-2023-00025
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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