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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The initial call was for a (b)(6) year old male patient weighing (b)(6) in cardiac arrest.The incident occurred at the patient's residence.Patient was conscious and then experienced severe respiratory arrest.He then went into cardiac arrest.The arrest was witnessed by his son who is a nurse.The patient was down for about 5-6 minutes prior to ems arrival.Upon ems arrival, patient was found lying on the kitchen floor with manual cpr being performed by his son (for less than 6 minutes).Ems crew secured the patient's airway and administered 2 rounds of 1:10 epinephrine.Manual cpr was continued by patient's son until the autopulse platform was deployed 4 minutes after ems arrival.The crew ensured that the patient was properly aligned on the platform and that the lifeband was not twisted.However, the autopulse platform displayed a "pull up lifeband" message.The crew pulled up on the lifeband and pressed "restart"; however, the error message did not clear.The customer attempted to restart the platform several times but was unsuccessful.Customer indicated that head immobilizers and shoulder restraints were used.The patient was not being moved at the time the error messages occurred.After 3-4 minutes, use of the autopulse was discontinued.The crew immediately reverted to manual cpr for about 12-13 minutes, which includes transport time to the ambulance.The patient was taken to the ambulance on a stretcher with a backboard and the platform in place.Customer indicated that the crew did not use zip ties to secure the platform to the backboard.As a result, the patient was repositioned on the platform after coming out of the house.The crew made another attempt to deploy the autopulse platform in the ambulance.However, the same "pull up lifeband" message occurred.The platform did not perform any compressions during the call.The crew immediately reverted to manual cpr for the duration of transport to the hospital, which was about 14 minutes.Patient was also given epinephrine and sodium bicarbonate during transport.Manual cpr was still in progress upon arrival to the hospital.The ems crew transferred patient care to the hospital staff.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead at the hospital by the ed physician on the same day.The cause of death is unknown.However, customer indicated that the patient had a history of cardiac arrest and ascending aortic aneurysm.The crew does not attribute the patient's death to the use of the autopulse.Customer does not believe that an autopsy was performed.

Manufacturer Narrative

Customer also indicated that the exact error codes (user advisory 2 - compression tracking error and user advisory 7 - discrepancy between load 1 and load 2 too large) were not known at the time of the event but were later seen in archive data.The autopulse platform in complaint was returned to zoll on 08/04/2014 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 of the returned platform shows that the battery clip was missing.The physical damage found during visual inspection is not related to the reported event of user advisory (ua) 2 (compression tracking error) and ua 7 (discrepancy between load 1 and load 2 too large) faults.The damage appears to have been caused by normal wear and tear (autopulse was manufactured in september of 2007).A review of the autopulse archive was performed and the reported complaint of ua 2 and ua 7 faults was confirmed.The archive data shows that ua 2 and ua 7 faults occurred on (b)(6) 2014, rather than on the reported event date of (b)(6) 2014.The archive also shows that a ua 18 (max take-up revolutions exceeded) fault occurred on the reported event date.However, the observed ua 18 fault is not related to the reported complaint.Functional testing was performed and the reported issue of ua 2 and ua 7 faults was not confirmed.The load cell characterization test indicated that both of the load cell modules are functioning as intended.The returned platform was subjected to a run-in test with a 95% patient test fixture and known good batteries for several hours.No faults or errors were observed.The platform passed the initial system test.Based on the investigation, the part identified for replacement was the battery clip.In summary, the reported complaint of ua 2 and ua 7 faults was confirmed based on the archive review but could not be reproduced during functional testing.The root cause for the ua 2, ua 7 and ua 18 could not be determined.However, user advisory 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.User advisory 7 is an indication that the patient is out of position or that the patient is not properly centered.User advisory 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.The physical damage found during visual inspection is unrelated to the reported complaint.Upon replacement of the battery clip, the platform was re-evaluated through functional testing and passed all testing criteria.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead at the hospital by the ed physician on the same day.The cause of death is unknown.However, customer indicated that the patient had a history of cardiac arrest and ascending aortic aneurysm.The crew does not attribute the patient's death to the use of the autopulse.

• 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: 3977977
• MDR Text Key: 4748579
• Report Number: 3003793491-2014-00386
• 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: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• 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: 08/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2007
• 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 Weight: 120