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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Cardiac Arrest (1762)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Product in complaint was returned to zoll on 08/05/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Event Description

A (b)(6) male patient experienced a cardiac arrest after jumping from a deadly height.The patient was transferred to the hospital by the responding agency.The autopulse was used at the hospital and was deployed without any issues.During use, the autopulse platform displayed multiple user advisory (ua) 17 (max motor on time exceeded during active operation) messages.The user attempted to reset the autopulse whenever a user advisory (ua) 17 was displayed, however the issue would not resolve.Manual cpr was performed during this time (exact length of time was not provided).Rosc (return of spontaneous circulation) was never achieved.After 30 minutes of use, the physician made the decision to discontinue use of the autopulse, as the patient had expired.An autopsy was not performed.The patient expired as a result of an induced cardiac arrest after jumping from a deadly height.The autopulse did not cause or contribute to the patient's death.Information regarding patient medication history, medications, bystander cpr, course of treatment during transport to the hospital and at the emergency room was not provided.No additional details were provided.

Manufacturer Narrative

The autopulse platform (12367) was returned to the manufacturer on 08/05/2015: visual inspection was performed and it was found that the load plate cover was torn and had holes in it, which can affect the sealing.The lcd backlight was also observed to be flickering.Please note that the physical damages noted during visual inspection are not related to the customer's reported complaint.A review of the autopulse platform's archive was performed and multiple user advisory (ua) 17 messages were observed on (b)(6) 2015, thus confirming the customer's reported complaint.Based on the archive data, li-ion battery (s/n) (b)(4) with a high remaining capacity (rc) 1357 was used on a medium sized patient.After a few seconds the device stopped performing compressions due to a user advisory (ua) 17 (max motor on time exceeded during active operation) message.The device continued for a few more seconds and then displayed a user advisory (ua) 10 (battery voltage out of range (replace battery)) message.A different nimh battery (s/n) (b)(4) was then used and the device stopped again due to multiple user advisory 17 messages.Functional evaluation of the returned autopulse platform was performed and the customer's reported complaint was confirmed.The platform was run with a 95% large resuscitation test fixture (lrtf) and stopped after 30 compressions were performed and displayed a user advisory (ua) 17 message.Further inspection determined that the drive train motor was defective and needed to be replaced.After replacing the drive train motor, the platform passed the run_in test for several hours and no other user advisories or faults were observed.Based on the investigation, the parts identified for replacement were the load plate cover, the lcd backlight and the drive-train motor.In summary, the customer's reported complaint of the platform displaying a user advisory (ua) 17 message was confirmed during archive review and ws replicated during functional evaluation.A root cause for the ua 17 messages was found to be that the drive train motor was defective.The physical damage found during visual inspection is unrelated to the reported complaint.These types of damages can occur due to normal wear and tear and/or physical abuse.After replacement of all the parts identified during investigation, the platform passed all final functional testing criteria.There were no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported patient death.The cause of patient's death was due to cardiac arrest after the patient jumped from a deadly height.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.Despite the user advisory message, autopulse compression and manual cpr were performed alternately for 30 minutes in the hospital.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, presenting the same workflow as manual cpr only.Rosc was never achieved.Use of the autopulse did not contribute to the patient's death.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5022936
• MDR Text Key: 23857649
• Report Number: 3010617000-2015-00469
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2006
• 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: 19 YR