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 01/18/2015

Event Type  malfunction  

Event Description

The initial call came in for a large, (b)(6) male patient involved in a vehicle accident.Patient was 5 feet 8 inches tall.He was driving on the road and a bystander in another car saw him slumped over in his car and called 9-1-1.Customer indicated that the patient was not a local resident so it is unknown what his medical history was and if he was taking any medications.Bystander cpr was not performed.First responders arrived on scene and initiated manual cpr for a few minutes.Ems then arrived on scene and deployed the autopulse platform within a few minutes of arrival.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.In the next 6-8 minutes, paramedics attempted to troubleshoot the message but were unsuccessful.They realigned the patient on the platform and pulled the lifeband up several times.Customer indicated that the patient was not being moved at this time.The crew discontinued use of the autopulse and immediately reverted back to manual cpr for the duration of time to the hospital, which was about 10 minutes.Patient was given epinephrine and amiodarone prior to the hospital and additional epinephrine, sodium bicarbonate and calcium gluconate in the hospital.Hospital staff provided patient with advanced cardiac life support (acls) care.Patient's condition went from ventricular fibrillation to ventricular tachycardia, to pulseless electrical activity (pea), then to sinus bradycardia.Patient achieved return of spontaneous circulation (rosc) in the hospital after 45 minutes of manual cpr.Patient was then transferred to a second hospital, which was an hour and 15 minutes away.Patient showed signs of acute myocardial infarction (mi) after rosc.He later expired the next morning, on (b)(6) 2015.An autopsy was not performed.The cause of the cardiac arrest was due to the mi.Customer indicated that the cause of death was presumed to be inferior infarction 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 one occurrence of a user advisory (ua) 2 (compression tracking error) and multiple ua 7 (discrepancy between load 1 and load 2 too large) messages on the reported event date of (b)(6) 2015.Based on the archive data, the ua 2 occurred on the first compression.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.The archive data also showed that multiple ua 7 messages occurred after the ua 2 message.The ua 7 messages may have occurred because the patient was out of position on the platform or because the patient was not properly centered.Both of these ua's prompt 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 also 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 one occurrence of ua 2 and multiple ua 7 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.The archive data also showed that multiple ua 7 messages occurred after the ua 2 message.The ua 7 messages may have occurred because the patient was out of position on the platform or because the patient was not properly centered.Both of these ua's prompt the user to "align patient and pull up on lifeband".It should be noted that the patient was not being moved when the ua 2 and ua 7 messages occurred.The customer reported that the crew realigned the patient on the platform and pulled the lifeband up several times but could not clear the ua messages.There were no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the ua 2 and ua 7 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 initial information indicated that the patient achieved return of spontaneous circulation (rosc) in the hospital after 45 minutes of manual cpr.However, he later expired the next morning.The cause of the cardiac arrest was myocardial infarction.Customer indicated that the cause of death was presumed to be inferior infarction 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: 4822708
• MDR Text Key: 5844551
• Report Number: 3010617000-2015-00313
• 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: 80 YR
• Patient Weight: 70