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 Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn: (b)(4)) stopped compressions and displayed "system error, out of service, revert to manual cpr" error message was confirmed based on review of the archive data and during the functional testing.The root cause for the reported complaint was due to a software communication error between the drivetrain motor and the processor board.During visual inspection of the returned platform, it was noted that the top cover was cracked at the lower corner on the patient's left-hand side.In addition, there was a crack observed on the front cover at the front-end area of the platform.The observed physical damages are unrelated to the reported complaint, and the damage found is characteristic of normal wear and tear.The autopulse platform is a reusable device and was manufactured in february 2010, and it is more than 10 years old, well beyond its expected service life of 5 years.The top and front covers will be replaced to address the physical damages.Review of the archive data indicated system error (latch error 203 - mailbox full) to have occurred around the customer's reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.Latch error 203 is a software logic related fault.The autopulse system software is designed to tolerate up to 2 software errors (fault code 46), but on the third error, the software triggers error 203 which is latched and requires service to unlatch.The platform was connected to the autopulse vision software to clear the system error.Upon further functional testing, the platform stopped after performing a few compressions due to fault code 27 (encoder fault), unrelated to the reported complaint.The autopulse platform stopped compressions multiple times to the fault code 27 as the encoder indicated that the driveshaft was turning too fast at the speed higher than 3000 rpm during compression, and therefore, the fault code 27 was triggered.The root cause was due to a defective integrated encoder gearbox, likely due to normal wear and tear.The defective integrated encoder gearbox will be replaced to remedy the issue.In addition, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The sticky clutch plate needs to be deburred to address the issue.Historical complaints were reviewed for service information related to the reported complaint, and there was one similar complaint reported for autopulse platform with serial number (b)(4).Ccr (b)(4) was reported on april 07, 2015, and the system error (latch error 203) was cleared/unlatched during service.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 was 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)(4)) was used to resuscitate a (b)(6)-year-old male patient in cardiac arrest.The patient had multiple comorbidities, including respiratory illness and presumed cardiac, which led to cardiac arrest.As reported, the cardiac arrest was witnessed by paramedics upon moving the patient into the ambulance.The patient immediately received manual cpr by the ems crew, followed by automated compressions performed by the autopulse platform.The autopulse performed a few compressions for less than a minute, and then, the platform displayed "system error, out of service, revert to manual cpr" error message.To troubleshoot the issue, the user inspected the lifeband, changed the battery, and re-started the autopulse platform.However, the error message did not clear.Manual cpr was performed by the ems crew for 15 minutes, starting immediately after the use of the autopulse platform was discontinued and during the troubleshooting.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead at the scene by the ems medical control physician and coroner.As per the customer, the patient's death was not related to the autopulse system.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10354147
• MDR Text Key: 201712805
• Report Number: 3010617000-2020-00736
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2020

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2010
• 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 Age: 62 YR
• Patient Weight: 102