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

Model Number MODEL 100

Device Problems Premature Discharge of Battery (1057); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The initial call was for a (b)(6) female patient weighing (b)(6) pounds in cardiac arrest on (b)(6) 2014 at 06:21 hours.The incident occurred at the patient's residence and was unwitnessed.The patient was down for an unknown length of time.Bystander cpr was performed by the sheriff's deputy.Length of time was not provided.There were 3 ems and 2 sheriffs on scene.Manual cpr was performed by the responding agency for 14 minutes prior to use of the autopulse.The autopulse was deployed without any issues.A "new" fully charged li-ion battery was exhausted after only 5 minutes of use.The autopulse was restarted, however, it stopped performing after just one compression.Medics did not have a spare battery on scene.No messages were observed on the lcd display after the reported issue was observed.Use of the autopulse was discontinued and manual cpr was continued for 8 minutes.Total length of time that cpr was performed including manual and automated was 27 minutes.The patient was slid onto the long spine backboard in the bathroom and moved into the hallway.However, the patient was not transported to the hospital.The patient was pronounced dead after consultation with the on-line physician.There were no signs or symptoms of trauma.Return of spontaneous circulation (rosc) was never achieved.The cause of the cardiac arrest is unknown.The cause of death is unknown.It is unknown if the autopsy report is complete or available.Patient had a history of diabetes and cardiac stents.Customer (assistant fire chief) did not attribute the patient's death to the autopulse stoppage.No further information was provided.

Manufacturer Narrative

Please see the following related mfr report: 3003793491-2014-00384 for autopulse li-ion battery with sn unk.Customer also reported that the daily check of the autopulse consisted of switching out the current battery, turning on the autopulse and once it started up, it was powered off and ready for use.Autopulse platform in complaint was returned to zoll circulation on 07/15/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that the load plate cover was torn.The physical damage found during visual inspection is not related to the reported event.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 3/2007).A review of the autopulse archive was performed and the reported complaint was confirmed.The archive data shows that the autopulse ran multiple times for a short period on the reported event date (b)(6) 2014, before it stopped.This was followed by multiple ua17 (max motor on time exceeded during active operation) faults.The archive also shows that the ua17 faults were exhibited when used with li-ion battery s/n (b)(4).The observed ua17 faults can contribute to the reported complaint.The root cause for ua17 faults could not be determined.However, user advisory 17 is an indication that the lifeband is twisted or battery voltage is low.Functional testing was performed and the reported issue could not be reproduced.The returned li-ion battery s/n (b)(4) was used to perform the run-in test for more than 30 minutes on the returned autopulse with a 95% patient test fixture.No faults or errors were observed.Furthermore, the load cell characterization test was also performed and which indicated that the load cells were functioning as intended.Battery management assessment was performed and the autopulse archive data analysis shows that li-ion battery s/n (b)(4) was used repeatedly and ran for a very short time.The archive also shows that the battery was fully charged at the time of the event.Based on the investigation, the part identified for replacement was the load plate cover.In summary, the reported complaint was confirmed based on the archive review, however it was unable to be reproduced during functional testing.Testing of the returned platform and the li-ion battery showed did not reveal any issues that may have contributed to the ua17 fault.Therefore, the cause for ua17 would likely be due to the lifeband being twisted resulting in the reported complaint.Upon replacement of the load plate cover, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• 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: 3976666
• MDR Text Key: 16542257
• Report Number: 3003793491-2014-00383
• 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: 07/08/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 08/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2007
• 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: 54 YR
• Patient Weight: 91