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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Device Displays Incorrect Message (2591); Issue With Displayed Error Message (2967)

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

Event Date 07/03/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 07/15/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

An initial call came in on (b)(6) 2015 for a code blue.Patient was a (b)(6) male, who weighed (b)(6) and was 5'10" tall.It is unknown what the patient's medical history was or if the patient was taking any medications.It is unknown what the patient's down time was.The cardiac arrest occurred at the patient's residence.The arrest was witnessed by the patient's wife prior to calling 9-1-1.Bystander cpr was performed by a neighbor for approximately 4 minutes.Upon arrival, customer indicated that the patient was already a code blue.No other agencies were on scene.The fire department-ems crew deployed the autopulse platform immediately upon arrival.However, the platform displayed a "fault" message.Customer indicated that the platform did not display any known user advisory (ua) codes to look up so the crew did not troubleshoot the issue.No compressions were provided by the platform.Use of the platform was discontinued and the crew immediately reverted to manual cpr for approximately 30 minutes until arrival at the hospital.The patient was extricated via backboard.Customer stated that head immobilizers and shoulder restraints were used.The hospital was 8 miles from the scene of event.During transport to the hospital, patient was also intubated, suctioned and given medications.Return of spontaneous circulation (rosc) was never achieved.It is unknown what the course of treatment in the er was.Patient was pronounced dead in the er on the same day.It is unknown if an autopsy was performed.The cause of the cardiac arrest and death are unknown.Customer stated that it is difficult to say if the patient's death was related to use of the autopulse.No further information was provided.

Manufacturer Narrative

Investigation results for the returned platform are 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) 7 (discrepancy between load 1 and load 2 too large) , ua 17 (max motor on time exceeded during active operation), ua 18 (max take-up revolutions exceeded) and ua 2 (compression tracking error) messages on the reported event date of 07/03/2015.Based on the archive data, li-ion battery with serial number (sn) (b)(4) was used on a small/medium patient.This battery was fully charged and had a high remaining capacity (rc) of 1201 when compressions were first initiated.The archive data indicates that the platform displayed two ua 7 messages after 23 seconds of compressions.The platform was restarted and stopped again after a few seconds due to multiple ua 17 messages.The platform was then restarted and stopped again after a few seconds due to multiple ua 18 messages.Compressions were restarted but the platform stopped after a few seconds due to multiple ua 2 messages.Contrary to what was initially reported, the platform did display multiple ua's and performed compressions in between the ua's.The customer's reported complaint that the platform displayed a "fault" message was confirmed.However, the reported complaint that the platform did not display any known ua codes and did not perform any compressions was not confirmed based on review of the archive data.The customer's reported complaint that the platform displayed a "fault" message was confirmed during functional testing of the returned platform.A run_in test was performed using a large resuscitation test fixture.However, the platform failed initial testing after seven minutes of compressions due to ua 17 messages.Further investigation determined that the drivetrain motor was defective and needed to be replaced in order to continue functional testing.A load cell characterization test was also performed, which verified that both load cell modules were functioning within specification.Based on the investigation, the part identified for replacement was the drivetrain motor.In summary, the customer's reported complaint that the platform displayed a "fault" message was confirmed through review of the platform's archive data.However, the reported complaint that the platform did not display any known ua codes and did not perform any compressions was not confirmed.The archive data indicated that multiple ua 7, ua 17, ua 18 and ua 2 messages occurred on the reported event date and that the platform performed compressions in between the ua messages.Per the autopulse maintenance guide, ua 7 is an indication that the patient is out of position or that the patient is not properly centered; ua 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform; ua 2 is an indication that the autopulse® has detected a change in lifeband® tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.It should be noted that the customer did not indicate whether the patient was being moved or whether the patient was removed from the platform.There were no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the ua 7, ua 2 and ua 18 messages.Specifically, a load cell characterization test was performed, which verified that both load cells were functioning within specification.Therefore, a root cause for these ua messages could not be determined.The ua 17 message found in the platform's archive data was replicated during functional testing.The root cause was determined to be a defective drivetrain motor.After replacement of the drivetrain motor, another run_in test using a 95% patient test fixture was performed for several hours without any occurrence of a ua or fault.The platform successfully passed all final functional testing.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.

• 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: 4948133
• MDR Text Key: 23017338
• Report Number: 3010617000-2015-00421
• 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
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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
• Patient Age: 74 YR
• Patient Weight: 82