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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Internal Organ Perforation (1987); Rupture (2208)

Event Date 11/14/2013

Event Type  Injury  

Event Description

Customer received a call on (b)(6) 2013, regarding an unresponsive (b)(6) year old male patient weighing about (b)(6).Patient was in bed with his wife for about an hour.Medic reported that the patient kicked his wife in bed.She thought he wanted her to move over.His wife heard him struggling and having trouble breathing so she woke up.She turned him on his side because she thought he was having a seizure and then called 911.Patient was down for about 5 minutes prior to customer's arrival.Upon arrival, customer began advanced life support (als), which included deployment of the autopulse.Manual cpr was performed by the medic for about 4 minutes while his partner went to get the autopulse.Patient was shocked once prior to deployment of the autopulse and was given amiodarone and then epinephrine.Ekg results indicated that the patient went from ventricular fibrillation to asystole.The autopulse platform was deployed with no issues.Customer stated that there was no device malfunction.The platform performed compressions for the entire time, from deployment to arrival at the hospital which was about 30 to 40 minutes.Patient was given another round of epinephrine in the ambulance.It took about 5 minutes to transport the patient to the hospital, which was 4 miles away.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead by the physician after 5 minutes at the hospital.Customer does not attribute the patient's death to the use of the autopulse.Customer does not have a copy of the autopsy report but was informed by the county's coroner that the report indicated that the patient's organ (liver) was damaged.It also revealed that the patient had an enlarged heart which may have led to the cardiac arrest and patient's death.The medic stated that the patient had no known medical history, which would include alcohol abuse and seizures.In addition, patient was not taking any medications.The chief does not know if the patient's damaged liver is attributable to the use of the autopulse.However, the medic stated that he does not know what else it could be.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: a visual inspection of the platform found that both head restraint brackets and the motor cover were cracked.Based on the condition of the returned platform, the cause of the damages appear to be normal wear and tear.A review of the archive data was attempted however, the archive data files were found to be corrupted and overwritten.As a result, no data could be retrieved.The platform was functionally tested and performed as intended.Load cell characterization was performed and load cell module 1 was found to be underreporting, however the failed load cell has been determined to be unrelated to the reported event.Please note that the customer indicated that the autopulse performed as intended and that there was no device malfunction.In addition, liver rupture is an injury that is known to possibly result from manual cpr.Data from 12 different published reports indicates that the rate of liver injuries from manual cpr is 2.40% (refer to white paper titled "injuries associated with delivery of manual cpr and autopulse cpr: a literature review" by howard michaels, m.D.).

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3621151
• MDR Text Key: 4159390
• Report Number: 3003793491-2014-00081
• 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
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2006
• 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 Outcome(s): Life Threatening; Other
• Patient Age: 43 YR
• Patient Weight: 100