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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Loss of consciousness (2418)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

An initial call came in regarding a (b)(6) male patient weighing (b)(6) lbs who was having difficulty breathing.The incident occurred at his house.Patient was 6 feet tall.According to his girlfriend, he had a cardiac history and a drug problem.It is unknown if the patient was taking any medication.The cardiac arrest was unwitnessed.Patient was found in his bedroom by his girlfriend and friends.They pulled him out to the hallway and initiated mouth to mouth.Customer arrived on scene within 2.5-3 minutes of the initial call.Patient was found unconscious and in cardiac arrest upon arrival.The sheriff's office was also on scene.Customer immediately initiated manual cpr.The autopulse platform was deployed within 5 minutes of arrival.There were no issues with deployment of the platform.The platform performed about 2 compressions, then stopped and advised the user to check the lifeband.The crew repositioned the patient, adjusted the lifeband and restarted the platform.The platform performed another 2 compressions, then stopped again and displayed the same message.The crew again repositioned the patient, adjusted the lifeband and restarted the platform.The platform performed another few compressions, then displayed the same message.This occurred for a total of about 5 times.The crew also powered the platform off and back on but the message did not clear.Medic did not know if a user advisory was displayed but indicated that he just saw a message advising him to check the lifeband.The crew performed manual cpr in between attempts to restart the platform.The platform provided a total of about 20 seconds of compressions.Medic stated that the patient was not being moved.Use of the autopulse was discontinued and the crew immediately reverted to manual cpr.Patient was extricated via stretcher and backboard and taken to the ambulance.Medic indicated that head immobilizers and shoulder restraints were used.Patient was given acls drugs in the ambulance and manual cpr was continued.However, medics noticed that the patient's skin color changed and made a call to the er physician at the hospital.The er physician pronounced the patient dead at 10:07.Resuscitation efforts ended in the ambulance.Return of spontaneous circulation (rosc) was never achieved.It is unknown if an autopsy was performed.The cause of cardiac arrest and death are unknown.However, the medic on scene does not attribute the patient's death to the autopulse and stated that the patient was asystole and already dead.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/03/2015 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 of the returned platform was performed and found no visible or physical damages to the platform.A review of the platform's archive data was performed and found multiple occurrences of user advisory (ua) 17 (max motor on time exceeded during active operation) and ua 2 (compression tracking error) on the reported event date of (b)(6) 2015.Based on the platform's archive data, li-ion battery with serial number (sn) (b)(4) with a high remaining capacity (rc) of 1262 was used on a small/medium, stiff, hard to compress patient.The platform stopped performing compressions after a few seconds due to a ua 17 message.The platform was then restarted and stopped again after a few seconds due to a ua 2 message; the archive data indicated that this occurred multiple times, thus confirming the customer's reported complaint that the platform performed a few compressions, then stopped and displayed a message advising the user to check the lifeband.Unrelated to the reported complaint, multiple ua 41 (patient temperature sensor failure) messages also occurred on the reported event date.The customer's reported complaint was not duplicated during functional testing.However, a brake gap inspection was performed which confirmed that the brake gap was out of specification at 0.016".The brake gap could not be adjusted back within the specification of 0.008" because both of the set screws did not lock into the encoder dimple locking hole causing the brake to disengage.The drive train motor was identified for replacement to remedy this issue.After replacement of the drive train motor, functional testing was continued using a 95% patient test fixture for several hours without any issues.A load cell characterization test was also performed, which confirmed that both load cells were functioning within specification.Unrelated to the reported complaint, investigation verified that the patient temperature sensor was functioning properly.Based on the investigation, the part identified for replacement was the drive train motor.In summary, the customer's reported complaint that the platform performed a few compressions, then stopped and displayed a message advising the user to check the lifeband was confirmed based on review of the platform's archive data but was not duplicated during functional testing.Review of the platform's archive data indicated that the platform stopped performing compressions after a few seconds due to a ua 17 message.The archive data then indicated that the platform was restarted and stopped again after a few seconds due to a ua 2 message; the archive data indicated that this occurred multiple times, which is consistent with the customer's reported complaint.Functional testing of the returned platform determined that the root cause of the ua 17 was due to the brake gap being out of specification.The brake gap could not be adjusted back within the specification of 0.008" because both of the set screws did not lock into the encoder dimple locking hole causing the brake to disengage.The drive train motor was identified for replacement to remedy the ua 17 message.After replacement of the drive train motor, functional testing was continued using a 95% patient test fixture for several hours without any issues.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the ua 2 messages that occurred on the reported event date.Specifically, a load cell characterization test was performed, which confirmed that both load cells were functioning within specification.Per the autopulse maintenance guide, a ua 2 may occur when the patient or lifeband is out of position, or if the lifeband is open during active operation.It should be noted that the initial information provided by the customer indicated that the crew repositioned the patient, adjusted the lifeband and restarted the platform after observing the ua 2 messages but the messages did not clear.A root cause for the ua 2 messages could not be determined.Unrelated to the reported complaint, review of the archive data indicated that a ua 41 message occurred on the reported event date.Evaluation of the returned platform verified that the patient temperature sensor was functioning properly.A root cause of the ua 41 could not be determined.However, possible causes could be due to improper storage of the device in a hot environment or exposure to direct sunlight for a period of time that will increase the internal temperature of the autopulse.There were also no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported patient death.The initial information indicated that the cause of the cardiac arrest and the patient's death are unknown.However, the medic on scene did not attribute the patient's death to the autopulse and stated that the patient was asystole and already dead.

• 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: 4849314
• MDR Text Key: 21053813
• Report Number: 3010617000-2015-00340
• 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: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• 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: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 42 YR
• Patient Weight: 113