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); Loss of consciousness (2418)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

The initial call came in on (b)(6) 2015 for a cardiac arrest.Patient was a (b)(6) year old male who weighed (b)(6) lbs.He had a history of cardiac problems with a documented myocardial infarction (mi) years ago.Patient was taking cardiac and blood pressure medication.The cardiac arrest occurred at the patient's home and was witnessed by his wife who found him at 6:30 am.Patient's wife initiated manual cpr until the fire department (fd) arrived.Patient was down for less than 10 minutes prior to arrival of the fd at 6:35 am.The fd took over manual cpr upon arrival.The ambulance then arrived at 6:40 am and deployed the autopulse platform within 2 minutes.There were no issues with deployment of the platform.The platform performed compressions for 10 minutes, then stopped and displayed a "system error, out of service, revert to manual cpr" message.The crew discontinued use of the autopulse and immediately reverted to manual cpr.The patient was extricated via an ambulance cot and taken to the hospital in 7 minutes.The hospital was 2.6 miles from the scene of event.Medics provided advanced cardiac life support (acls) care to the patient during transport to the hospital.Patient was given multiple rounds of epinephrine in the ambulance.In addition, manual cpr was continued until resuscitation efforts were stopped in the emergency room (er).Return of spontaneous circulation (rosc) was never achieved.It is unknown what the course of treatment in the er was.Patient was pronounced dead by the er physician.It is unknown if an autopsy was performed.The cause of cardiac arrest and death are also unknown.However, the customer does not attribute the patient's death to the autopulse and indicated that the patient did not have a heart rhythm to begin with.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 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 was performed and no damages to the platform were observed.When the platform was powered on, a "system error - out of service, revert to manual cpr" message was displayed, thus confirming the reported complaint.After clearing of the "system error" message, testing was continued.During inspection, no deficiencies were observed with the device which could have caused or contributed to the observed "system error".Load cell characterization was performed which confirmed that both load cell modules were functioning within specification.A brake gap inspection was also performed and verified that the brake gap was within the specification of 0.008" ±0.001".A run_ in test was performed using a large resuscitation test fixture for several hours, with no other user advisories, system errors or warnings exhibited.The autopulse performed as intended after the "system error" was cleared.A review of the platform's archive was performed and confirmed that the reported "system error - out of service, revert to manual cpr" message occurred on the reported event date of (b)(6) 2015.On this date, there were also two user advisory (ua) 17 codes (max motor on time exceeded during active operation) and a single occurrence of a warning 1 - low battery warning.A cause for the ua 17 codes could not be determined.No device issues were observed which may have led to the ua 17 codes.Specifically, inspection of the brake gap as well as the motor controller showed no issues.The observed warning 1 occurred as expected due to use of a li-ion (s/n (b)(4)) battery that had insufficient remaining charge at the time the warning was displayed.However, the data does show that the battery had a sufficient number of test cycles performed.In order to determine the cause of the observed "system error - out of service" message, the platform's archive data was reviewed for several days prior to the event date.The archive showed that between (b)(6) 2015 and (b)(6) 2015, there were multiple instances of the platform displaying fault 46 (software error codes) followed by latch error 203 codes (trap errors).No mechanical issues were identified during evaluation of the platform that may have caused or contributed to these observed codes.Based on the archive evaluation with zoll (b)(6), the autopulse platform displayed the latch error 203 codes as intended, since the system software is designed to tolerate up to two software error codes (fault 46 codes) before displaying this error code.The "system error - out of service" message experienced by the customer on (b)(6) 2015 is also considered to have occurred as intended; the system software will give this error when three instances of the latch error 203 (trap errors) codes have occurred.Based on the investigation, no parts were identified for replacement.In summary, the reported complaint was confirmed based on functional evaluation as well as platform archive review.Based on the investigation, the "system error" message placing the platform out of service on (b)(6) 2015, occurred as expected due to multiple fault 46 codes and latch error 203 codes occurring in succession between (b)(6) 2015 and (b)(6) 2015.The autopulse system software is designed to tolerate up to 2 software errors, such as the observed fault 46 codes, and is designed to then display a latch system error 203.Multiple instances of these errors in succession are then expected to place the platform out of service, as was observed in the archive on (b)(6) 2015.From the device inspection, there is no indication that the device caused or contributed to the patient outcome.Based on additional information received, the cause of the cardiac arrest and subsequent death are unknown.It should be noted that the customer does not attribute the patient's death to the autopulse and also indicated that the patient did not have a heart rhythm at the time treatment began with the autopulse platform.Since no device deficiencies were observed during evaluation, no parts were replaced on the platform.Following service, which included a brake gap inspection, load cell characterization testing, and clearing of the "system error - out of service, revert to manual cpr" message, the device passed all test criteria.

• 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: 4743993
• MDR Text Key: 5706654
• Report Number: 3010617000-2015-00255
• 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: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2007
• 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: 42 YR
• Patient Weight: 113