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 11/27/2014

Event Type  malfunction  

Event Description

It was reported that an initial call came in on (b)(6) 2014 for a (b)(6) year old female patient weighing (b)(6) kg.The reported incident occurred at the patient's residence.The cardiac arrest was unwitnessed and bystander cpr was not performed.Patient was down for about 20 minutes prior to the fire department's arrival.No other responding agencies were on scene.The crew immediately initiated manual cpr upon arrival.The autopulse platform was deployed within 5-7 minutes without any issues.However, when the "start/continue" button was pressed to begin compressions, the platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.The crew repositioned the patient and pulled up on the lifeband but the message did not clear.The crew then discontinued use of the autopulse.No compressions were provided by the autopulse.Manual cpr was still being performed during this time.Patient was given epinephrine and amiodarone while inside the house.She was also shocked 6 times with a defibrillator.Patient achieved return of spontaneous circulation (rosc) on scene after 20 minutes of manual cpr.The crew loaded the patient via a long back board for transport to the hospital.The hospital was 15 minutes from the scene of event.Patient was alive upon arrival at the hospital.Customer did not know what the course of treatment in the er was.However, patient died about an hour after arrival.Patient's medical history was listed as unknown.The cause of the cardiac arrest is unknown.Per the deputy chief, the cause of death is presumed to be due to cardiac arrest.The deputy chief does not attribute the patient's death to the autopulse.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 12/10/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The reported user advisory (ua) 45 (not at "home" position after power-on/restart) was cleared while the customer was on the phone with zoll tech.Support rep.On (b)(6) 2014.After the ua 45 message cleared, a ua 12 (lifeband not present) message then displayed; however, zoll tech.Support rep.And the customer were not able to clear this message.Investigation results for the returned platform as follows: visual inspection of the returned platform showed no physical damages to the platform.A review of the autopulse platform's archive was performed and the reported complaint of a user advisory (ua) 45 (not at "home" position after power-on/restart) fault was confirmed.The archive data showed that ua 45 faults occurred on the reported event date of (b)(6) 2014.In addition, the archive showed that a ua 12 (lifeband not present) fault occurred on the reported event date.However, this user advisory was not related to the reported complaint.Functional testing was performed and the reported complaint could not be reproduced.The platform ran for 30 minutes with a test manikin and an additional 36 minutes with a large resuscitation test fixture (equivalent to a 250 pound patient) and no problems were observed.The platform passed functional testing.Based on the investigation, no parts were identified for replacement to remedy the reported complaint.However, the processor board was replaced as a precaution.In summary, the reported complaint of a ua 45 fault was confirmed based on the platform's archive review but could not be reproduced during functional test.The ua 45 was cleared by the customer during troubleshooting with zoll tech support.The root cause for the ua 45 fault was due to the lifeband straps not being pulled completely out prior to turning on the platform.The root cause for the ua 12 fault was due to the belt clip not being detected in the spool shaft.Upon replacement of the processor board, the platform was re-evaluated through functional testing and ran for approximately 21 minutes with a test manikin.No problems were found.The platform passed all testing 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: 4375247
• MDR Text Key: 5234893
• Report Number: 3010617000-2014-00678
• 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: 12/04/2014

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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: 77 YR
• Patient Weight: 61