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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problems Pulmonary Embolism (1498); Injury (2348)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.The patient's death was not related to the autopulse device.Based on available information, the event of "a massive fat embolism in the lungs and multiple injuries" were possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.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.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".

Event Description

During patient use, after every shock, the autopulse platform performed 2 to 3 compressions and stopped.The crew pulled up the lifeband each time to restart the compressions and the platform continued to stop after performing 2 to 3 compressions.Unknown if manual cpr was performed.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead.Per forensic autopsy results, the patient was diagnosed with a massive fat embolism in the lungs and multiple injuries.The information on the type and location of the injuries were not provided.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6)) stopped compressions" was confirmed based on the archive data review, but not during the functional testing.No device malfunction was observed during the testing and the platform worked as intended.The archive data showed that the autopulse platform stopped compressions due to user advisory (ua) 17 (max motor on time exceeded during active operation) error message.The probable root cause for the ua17 error was due to the stiffness of the patient's chest.Upon visual inspection, no physical damage was observed.Unrelated to the reported complaint, observed that the encoder drive shaft does not rotate smoothly, and exhibits binding and resistance.The clutch plate needs to be deburred to address the observed problem.The cause for the observed encoder drive shaft problem was due to normal wear and tear of the device.The autopulse platform was manufactured in 2011 and is 9 years old, well beyond the expected service life of 5 years.The autopulse platform passed the initial functional testing without any fault or error.The archive data review showed that the autopulse platform performed 4 sessions of 182 compressions, 121 compressions, 67 compressions and 7 compressions using the autopulse li-ion battery (sn (b)(6)) with remaining capacity of 1456 mah.After performing 4 sessions of compressions, the platform stopped compression and displayed ua02 (compression tracking error) error message.The user pressed restart to clear the error.The autopulse platform was used again with the same battery with remaining capacity of 1120 mah, performed 4 sessions of 209 compressions, 190 compressions, 40 compressions and 5 compressions.After performing 4 sessions of compressions, the platform stopped compression and displayed ua17 error message.The user pressed restart to clear the error.The autopulse was used again with the same battery.The autopulse stopped compressing 3 more times due to ua17 after performing 3 sessions of 7 compressions, 4 compressions and 6 compressions.The max load sum values indicated that the patient's chest was hard and stiff to compress.User advisory is a clearable error message, ua02 error message alerts the operator as the drive shaft rotates and shortens/tightens the life band (compresses the chest), and the load sensors do not see the expected increase in load.This typically occurs if the patient is misaligned on the platform or the life band is opened or in the incorrect position during take up/compression.Clear the ua by pressing the restart button.Ua17 error message alerts the user that the drive train motor did not reach the target depth within specification when used on a medium/large size stiff patient or the lifeband is twisted.The recommended actions to take for this type of user advisory are: pull up the lifeband completely, ensure that the patient and the lifeband are properly aligned, and press restart.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Upon customer approval, service will be performed and the autopulse platform will be further tested to full specification.The patient's death was not related to the autopulse device.Based on available information, the event of "a massive fat embolism in the lungs and multiple injuries" were possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.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.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9858189
• MDR Text Key: 184994556
• Report Number: 3010617000-2020-00282
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other