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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed "realign patient "error message was not confirmed during functional testing but was confirmed during archive data review.Analysis of the autopulse platform revealed no problems with the board which may have contributed to the reported complaint.No physical damage was observed during the visual inspection.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The sticky clutch plate was deburred.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in 2010.The platform has also exceeded its expected service life of 5 years.During functional test, unrelated to the reported issue, the platform displayed system error 139 (unable to hold compression position) error message upon power on.The root cause of the issue was due to the brake gap being out of specification and the gap cannot be readjusted to be within specification.A replacement of the drivetrain is required to remedy the problem.After the drive train motor replacement, the autopulse was subjected to the run in test using 95% patient large resuscitation test fixture for 30 minutes and passed with no issue or faults observed.The archive data revealed a user advisory (ua) 02 (compression tracking error) on the customer reported event date, thus confirming customer complaint.Advisory (ua) 02 error message alerts the operator as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.This typically occurs if the patient is misaligned on the platform or the lifeband is opened or in the incorrect position during take up/compression.The load cell characterization test confirmed both load cells modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).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, the fire department responded to a (b)(6) years old male patient who was in cardiac arrest.The cause for cardiac arrest was related to a drug overdose.Emc crew arrived 15 minutes after the call.No bystander cpr was performed.The autopulse started compressing and performed total (b)(4) compressions, however, it stopped 6-8 times during this period and displayed "realign patient "error message.The patient was realigned and lifeband readjusted, however, the same issue persisted.The crew then reverted to manual cpr for 8 minutes.Rosc (return of spontaneous circulation) was not achieved and the patient was pronounced at hospital after transport.According to the customer, the patient had been down for a long time prior to ems arrival.Customer stated that platform did not attributed to the patient death.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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 ((b)(6), circulation, 2016).Death is an expected outcome for ohca.

Event Description

On (b)(6) 2018, the fire department responded to a (b)(6)-years old male patient who was in cardiac arrest.The cause for cardiac arrest was related to a drug overdose.Emc crew arrived 15 minutes after the call.No bystander cpr was performed.The platform was implemented first on the floor of the patient's leaving room and then continued in the ambulance during the transport.The autopulse started compressing and performed total (b)(4) compressions, however, it stopped 6-8 times during this period and displayed "realign patient "error message.The patient was realigned and lifeband readjusted.Per reporter, lifeband was loosening up during the decompression phase causing the platform to display a "realign patient "error message.In addition, the customer replaced the battery, however, the same issue persisted.The crew then reverted to manual cpr for 8 minutes.Rosc (return of spontaneous circulation) was not achieved and the patient was pronounced at the hospital after transport.According to the customer, the patient had been down for a long time prior to ems arrival.The customer stated that the platform did not attribute to the patient death.According to the reporter, the patient's death was not related to the delay caused by the device issue.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: 7802618
• MDR Text Key: 117868952
• Report Number: 3010617000-2018-00852
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2018

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: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2010
• 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: 25 YR