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 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

The report of user advisory (ua) 19 (max applied load exceeded) error message was confirmed through analysis of the retrieved archive data from the autopulse platform (sn (b)(4)).The archive data indicated that on the event date, the platform was used on a large patient weighing approximately (b)(6).And displayed user advisory (ua) 19 error message.The cause of the user advisory (ua) 19 error message is attributed to the driveshaft meeting resistance when the platform was operated on a large or stiff patient.During the functional testing, the platform performed continuous compressions with a large resuscitation test fixture without error.There was no device malfunction observed.The investigation verified that the drivetrain motor brake gap was within the specification.A load characterization check was performed and confirmed that both load cell modules are functioning within the specification.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The user advisory (ua) 19 error message recorded in the archive data is easily clearable by the user.The user advisory (ua) 19 error message alerts the operator that the load plate has detected too much weight being applied.The user advisory (ua) 19 error message can be cleared by restarting the platform.Based on the archive data, the user advisory (ua) 19 error messages were due to the platform being used with a patient beyond the recommended size parameters.The autopulse is designed for adults with a weight of no more than 300 lbs (136kg), with a chest circumference of 29.9 to 51.2 inches (76 to 130 cm), and a chest width of 9.8 to 15 inches (25 to 38 cm).There was no physical damage was observed on the returned autopulse platform during visual inspection.However, unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is the characteristics of normal wear and tear.The returned autopulse platform was manufactured in january 2015 and is almost 5 years old.Deburring of the clutch plate was performed to remedy the encoder drive shaft issue.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.In this case, when the autopulse platform (sn: (b)(4)) was used on an (b)(6) year-old male patient in cardiac arrest, the platform displayed an error message, and no compressions were performed.Manual cpr was performed for 30-35 minutes.The patient didn't survive and was pronounced dead.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 ((b)(6), 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 the call, the autopulse platform (sn: (b)(4)) was used on an (b)(6) year-old male patient in cardiac arrest.The patient was placed on the autopulse platform, and the lifeband came down on the patient and was tightened.However, no compressions were performed, and the platform displayed a user advisory (ua) 19 (max applied load exceeded) error message.Manual cpr was performed for 30-35 minutes.The patient didn't survive and was pronounced dead.According to the customer, the patient's death was not related to the platform.

Manufacturer Narrative

The reported complaint of user advisory (ua) 19 (max applied load exceeded) error message was confirmed based on analysis of the retrieved archive data but not during the functional testing.There are two possible root causes for the observed ua19.One possible root cause could be due to the load plate detecting too much weight being applied on the platform, most likely due to the stiffness and hard-to-compress of the patient's chest.Another possible root cause could be either one or both sides of the lifeband was most likely twisted, or the lifeband outer fabric layer was jammed at the roller/skirt areas.The autopulse platform possibly pulled in the material on the side where the lifeband fabric was jammed, but the patient's chest recoil was not forceful enough to pull it back out.Visual inspection of the returned autopulse platform revealed that the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to sticky clutch plate.This type of encoder drive shaft issue can occur due to normal wear and tear.The returned platform was manufactured in january 2015 and is 5 years old and has reached its expected service life of 5 years.Deburring of the clutch plate was performed to remedy the encoder drive shaft issue.A review of the autopulse platform archive was performed and revealed that the platform failed during patient use with ua19, thus, confirming the reported complaint.Based on the archive data, the load plate had detected too much weight being applied (> 270 lbs /123kg), and the load exceeded applied_load_max plus the patient's torso weight (load measured at the start of take-up).Initially, the platform performed three sessions of successful compressions.Fourteen seconds later, the platform was turned off by the user and turned back on for an unknown reason.Upon powering up, the platform displayed user advisory (ua) 12 (lifeband not present).The possible root cause for the observed ua12 could be due to the original lifeband was removed or replaced with a different lifeband.User managed to clear the ua12, and the autopulse platform performed 2 compressions, and then the platform stopped due to ua19 (max applied load exceeded).According to the archive, max load sum exceeded 317 lbs.The platform was re-started and ua19 was cleared.The platform performed one compression and then stopped again due to reoccurrence of ua19.The archive revealed that max load sum exceeded 303 lbs.The error message ua19 was cleared again, and the platform performed two sessions of 10 and 8 compressions.Then, the platform stopped due to ua07 (discrepancy between load 1 and load 2 too large).The load sensing system detected a weight/load imbalance between the two load cells.The error message was cleared, and the platform performed 5 compressions, and then, it stopped again due to ua07.The error messaged was cleared, and few more compressions were performed.Eventually, the platform stopped compressions again due to ua19.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Ua07 is an indication that the load sensing system has detected a weight/load imbalance between the two load cells.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to mitigate patient movement and press restart to clear the error message.Ua12 error message alerts when the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.During the functional testing, the autopulse platform performed continuous compressions with a large resuscitation test fixture (lrtf) without any fault or error.The investigation verified that the drivetrain motor brake gap was within the specification.Also, a load characterization check was performed and confirmed that both load cell modules are functioning within the specification.Following service, including the deburring of the clutch plate, the platform passed all testing criteria.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9527682
• MDR Text Key: 177423360
• Report Number: 3010617000-2019-01137
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: 12/09/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 50