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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/09/2015

Event Type  malfunction  

Event Description

An initial call came in at 09:19 for a (b)(6).Patient had a history of chronic health problems including (b)(6), hypertension and hypothyroid.Patient was taking ribavirin for the (b)(6), hypertension medication, hypothyroid medication and zoloft.The incident occurred at the patient's residence.At 07:00, patient went outside.Sometime after, a family member came out to find her (exact time was not provided).Bystander cpr was not performed.First responders arrived within 6 minutes of dispatch and initiated manual cpr for about 30 minutes.Ems arrived on scene at 09:44 and continued manual cpr for 3-6 minutes.The autopulse platform was then deployed.The platform displayed an "initializing" message followed by an "align patient and pull up on lifeband" message.Paramedics reported that the lifeband did not size down on the patient.The crew made 3 attempts to position the patient and align the patient and lifeband over the yellow marks on the platform but the message did not clear.Paramedics then discontinued use of the autopulse and reverted back to manual cpr for the duration of time to the hospital, which was 19 minutes.Patient was given 9 rounds of epinephrine prior to the hospital.Return of spontaneous circulation (rosc) was never achieved.Manual cpr was performed for a total of one hour and 40 minutes.The patient was pronounced dead by the physician at 10:45.An autopsy was not performed.The cause of the cardiac arrest and death are unknown.However, customer indicated that the patient had pulseless electrical activity (pea) during the entire call and does not attribute the patient's death to the autopulse.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 05/27/2015 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) 2 (compression tracking error) messages on the reported event date of (b)(6) 2015.A ua 2 may indicate a false take up.False take up means that pressure was applied to the load cell(s) before "take up" was completed causing slack to be present on the lifeband.The platform will attempt to perform a compression but no increase in pressure will be detected as the driveshaft rotates.This information is consistent with the customer's reported complaint that the lifeband did not size down on the patient.The lifeband may have been opened during active operation causing a decrease in load on the load cells as the driveshaft was rotating.A ua 2 prompts the user to "align patient and pull up on lifeband", thus confirming the customer's reported complaint that the platform displayed an "align patient and pull up on lifeband" message.The customer's reported complaint was not duplicated during functional testing.The returned platform was tested with a large resuscitation test fixture for several hours without any occurrences of a user advisory, fault, system error or warning.A load cell characterization test was performed, which confirmed that both load cell modules were functioning within specification.Based on the investigation, no parts were identified for replacement.In summary, the customer's reported complaint that the platform displayed an "align patient and pull up on lifeband" message and that the lifeband did not size down on the patient was confirmed during review of the platform's archive data but was not replicated during functional testing.Review of the archive data found multiple occurrences of ua 2 messages on the reported event date.A ua 2 may indicate a false take up.False take up means that pressure was applied to the load cell(s) before "take up" was completed causing slack to be present on the lifeband.The platform will attempt to perform a compression but no increase in pressure will be detected as the driveshaft rotates.This information is consistent with the customer's reported complaint that the lifeband did not size down on the patient.A ua 2 message prompts the user to "align patient and pull up on lifeband".It should be noted that the customer reported that the crew made 3 attempts to position the patient and align the patient and lifeband over the yellow marks on the platform but the message did not clear.There were no device deficiencies found during evaluation of the returned 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 cell modules were functioning within specification.The returned platform was tested with a large resuscitation test fixture for several hours without any occurrences of a user advisory, fault, system error or warning.Based on the available information and the evaluation of the platform, a root cause for the customer's reported complaint could not be determined.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 cause of the cardiac arrest and death are unknown.However, the customer indicated that the patient had pulseless electrical activity (pea) during the entire call and did not attribute the patient's death to the autopulse.

• 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: 4822726
• MDR Text Key: 18887523
• Report Number: 3010617000-2015-00314
• 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: 05/13/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 06/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2008
• 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
• Treatment: MANUAL CPR
• Patient Age: 58 YR
• Patient Weight: 73