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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 01/24/2015

Event Type  malfunction  

Event Description

A (b)(6) male patient experienced a cardiac arrest in the driveway of his residence.The arrest was unwitnessed.The patient was down for an unknown length of time.Bystander cpr was performed by the patient's neighbor for about 5 minutes.The first responders arrived on scene and took over manual cpr for another 5 minutes.Upon arrival of the ambulance, patient was found lying pulseless on the driveway.It is unknown what the patient's weight was.The autopulse platform was deployed without any issues.The platform performed about 10 compressions and then stopped.The ems chief confirmed that the crew looked at the platform's display but did not see any error messages.The crew reset the lifeband and attempted to restart the platform but it did not restart.Manual cpr was performed during this time for about 3 minutes.The crew discontinued use of the autopulse and immediately reverted to manual cpr for the duration of transport to the hospital, which was about 30 minutes.The patient was extricated via a backboard to the stretcher and taken to the ambulance.The hospital was about 17-18 miles from the scene of the event.During transport, patient was treated with iv, intubation and medications (epinephrine, sodium bicarbonate).Return of spontaneous circulation (rosc) was never achieved.About 5-10 minutes after arrival at the hospital, manual cpr was discontinued and patient was pronounced dead by the er doctor.Patient had a history of severe scoliosis and alzheimer's disease.An autopsy was performed; however, the report is not available.The cause of the cardiac arrest is unknown.The cause of the patient's death is presumed to be cardiac arrest.The ems chief does not attribute the patient's death to the autopulse.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/06/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and found that the top, front and bottom covers were damaged.From the condition of the platform, the damages appear to have been caused by normal wear and tear.Functional testing was performed with a large resuscitation test fixture for several hours, with no user advisories (ua's) or warnings displayed.Load cell characterization was performed as well, and found both load cells to be operating within specification.A brake gap inspection was performed, which verified that the brake gap was within the specification of 0.008", +/- 0.001".A review of the platform's archive data was performed and the following user advisory (ua) codes were observed on the reported event date of (b)(6) 2015: ua 7 (discrepancy between load 1 and load 2 too large), ua 2 (compression tracking error), and ua 18 (max take-up revolutions exceeded).Based on load cell characterization testing, which showed that the load cells functioned as intended, the probable cause of the observed ua 7 codes has been determined to be improper positioning of the patient onto the platform or possible patient and/or platform movement while compressions were being performed.No mechanical issues were identified with the platform that may have caused or contributed to the ua 2 codes.Therefore, it is likely that the ua 2 codes occurred as a result of patient misalignment on the platform or from the lifeband being opened.No mechanical issues were identified with the platform that may have caused or contributed to the ua 18 codes.Ua 18 codes can occur as result of no load change detected at the load plate.In this case, it appears the ua 18 codes occurred approximately 1.5 hours after the platform had been deployed to treat the patient.From this, it can be concluded that the ua 18 did not occur during patient treatment, but rather at the customer's site.Since the data shows that no load was placed on the platform at the time these codes occurred, it's concluded that the ua 18 codes occurred as expected, due to the user turning on the platform and pressing the "start/stop" button with no load on the device.Based on the investigation, the parts identified for replacement were the top cover, front cover and bottom cover.In summary, the reported event of the platform stopping operation was confirmed based on platform archive review.The archive shows that on the reported event date of (b)(6) 2015, the platform displayed multiple ua 2, ua 7 and ua 18 codes.Based on the evaluation of the device, there were no mechanical issues identified with the autopulse platform that may have caused or contributed to the observed codes.Based on additional information provided, the cause of the patient outcome was cardiac arrest and the user did not attribute the patient outcome to the autopulse platform.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4537949
• MDR Text Key: 5517311
• Report Number: 3010617000-2015-00121
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2007
• 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
• Treatment: MANUAL CPR
• Patient Age: 78 YR