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

Model Number MODEL 100

Device Problem Device Stops Intermittently (1599)

Patient Problem Cardiac Arrest (1762)

Event Date 07/26/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 08/12/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

On (b)(6) 2015 at 13:44, the doctor's helicopter arrived on scene.At 14:13, the crew left the scene.The autopulse platform was in use at this time but stopped and restarted for an instant.The doctor attempted to restart the platform several times but the issue did not resolve.The doctor discontinued use of the autopulse and immediately reverted to manual cpr.Return of spontaneous circulation (rosc) was not achieved in the helicopter.At 14:19, the helicopter arrived at the hospital.The patient was taken to the er but later passed away.It is unknown if there were signs or symptoms of trauma.The patient was pronounced dead by the doctor in the hospital.The criteria for pronouncement was not provided.An autopsy report is not available.The cause of the cardiac arrest and patient's death were not provided.The date of death was not provided.The customer did not provide their opinion on the relationship between the issue and the autopulse.Per the patient's medical chart, the patient's physique was stout in structure with proper chest size.The hospital has refused to provide any additional patient information.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation on (b)(4) 2015.Investigation results as follows: visual inspection of the returned platform was performed and it was found that the load plate cover was defective and had holes in it.The top and bottom cover were observed to be cracked and the battery bay compartment was damaged.Please note that the physical damages observed during visual inspection are unrelated to the customer's reported complaint.A review of the autopulse platform's archive was performed and multiple user advisories such as 02 (compression tracking error), 08 (motor controller fault) and 45 (not at "home position after power-on/restart) messages were observed on the reported event date, thus confirming the customer's reported complaint.User advisory 2 is an indication that when the driveshaft rotates and shortens and the lifeband compresses the chest, the load sensors do not see the expected increase in the load.The probable causes for this ua to occur are when the patient or lifeband is out of position, or if the lifeband is opened during active operation or pressure has been applied to the load cells before "take up" has been completed.User advisory 8 is an indication that there was a malfunction with the motor controller.This occurs when there is an internal component error or malfunction.User advisory 45 is an indication that the driveshaft is out of the "home" position when the autopulse is powered on.This occurs if the lifeband was cut before being properly removed, allowing the cut ends to unwind without the driveshaft being rotated or if there is an internal component error or malfunction.Functional evaluation of the returned platform was performed and the platform stopped after a few compressions during the run_in test and displayed a user advisory 8 message.Further inspection determined that the drive train motor was defective.After the drive train motor was replaced, another run-in test using a 95 % patient test fixture was performed for several hours and no user advisories or warnings were exhibited.Load cell characterization testing was performed which found that both load cells were functioning within specification.Based on the investigation, the parts identified for replacement were the drivetrain assembly, motor cover, top and bottom cover and battery bay compartment.In summary, the customer's reported complaint was confirmed through review of the platform's archive and functional testing.Review of the platform's archive found several user advisories (uas) such as 2, 8, and 45 on the reported event date.There were no device deficiencies which could have caused or contributed to the reported user advisory 2 and 45 messages.User advisory 8 occurred as a result of a defective drive train motor.A load cell characterization test was also performed, which verified that both load cells were functioning within specification.The physical damage found during visual inspection is unrelated to the reported complaint and appeared to have been caused by normal wear and tear and/or physical abuse.There were also no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported patient's death.The cause of death was presumed to be drowning or wound shock.Cardiogenic could not be ruled out.The customer did not indicate if the patient's death was related to the autopulse.However per medical staff, if there was any attribution of the patient's death to the autopulse, then they would have already informed zoll.

Event Description

Additional information provided by zoll (b)(4).The cardiac arrest occurred outside and was unwitnessed.It is unknown when the last time the patient was seen.The reason for the doctor's helicopter call was because the patient fell into sea from a ship.The patient was rescued by the maritime safety agency's boat.An aed was applied and indicated a non-shockable rhythm.Manual cpr was initiated by the maritime safety agency for an unknown length of time.The autopulse was deployed at 14:09.It is unknown how long compressions were performed for before the platform stopped.Customer stated that there were probably no error messages displayed when the platform stopped.However, there was an audible message advising the user to "please restart".Customer restarted the platform but compressions did not resume.Manual cpr was not performed at this time.Use of the autopulse was discontinued after the customer made several attempts to resume compressions.Customer reverted to manual cpr until arrival to the hospital.Return of spontaneous circulation (rosc) was not achieved at the hospital.Patient expired at 14:46 on the same day.The cause of death was presumed to be drowning or wound shock.Cardiogenic could not be ruled out.The customer did not indicate if the patient's death was related to the autopulse.Per the medical staff, if there was any attribution of the patient's death to the autopulse, then they would have already informed zoll.Information such as age, gender, weight, height, patient's past medical history are unknown.It is also unknown if there were other agencies who responded to the call, how the patient was extricated, and if head immobilizer and shoulder restraints were used.

• 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: 5039200
• MDR Text Key: 24430895
• Report Number: 3010617000-2015-00476
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2008
• 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