MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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 12/08/2021

Event Type  malfunction  

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.According to available information, the death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.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

During device use on a cardiac arrest patient, the autopulse platform (sn (b)(4)) displayed a user advisory (b)(4) discrepancy between load 1 and load 2 too large) error message.Return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead on the scene.No additional information was provided.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, the msa evaluate the incident and it was determined that the death was not related to the autopulse device.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and the archive data review.The root cause for (ua) 07 was due to defective load cell modules.The defective load cell modules were likely attributed to mishandling such as a drop or a defective component.During visual inspection, unrelated to the reported complaint, noticed a hole on the load plate cover that affects the watertight seal.The likely root cause for this observed physical damage is user mishandling.The load plate cover was replaced to address the damage.Also, noticed the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.The clutch plate was deburred to address the sticky clutch problem.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.The autopulse platform failed the initial functional testing due to (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.The load cell characterization test results confirmed that both load cell modules exceed normal parameters and were replaced to remedy the (ua) 07 error.A review of the archive data was performed and showed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) on the customer's reported event date, thus confirming the reported complaint.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.A load cell characterization test was performed and confirmed both cell modules are functioning within the specification.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 previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: 13122140
• MDR Text Key: 283782151
• Report Number: 3010617000-2021-01232
• 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: 01/27/2022

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: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• 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