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

Model Number MODEL 100

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Loss of consciousness (2418)

Event Date 03/29/2014

Event Type  malfunction  

Event Description

Customer reported that they responded to a call regarding an unconscious (b)(6) male, weighing about (b)(6) pounds.Patient was found lying down at his place of residence by his wife.Patient's spouse estimated that patient was down for approximately 15-20 minutes, as that was the last time that she had communicated with him.Bystander cpr was not performed prior to ems arrival.Ems arrived on scene and patient went into a cardiac arrest.The autopulse was immediately deployed without any issues.An ekg was performed which revealed that the patient was asystole.All vitals were absent.The autopulse performed 9 compressions and then stopped and displayed user advisory (ua) 18 (max take-up revolutions exceeded) and ua 02 (compression tracking error) messages.7 rounds of epinephrine were administered with no change in the patient's condition.No other cardiac medications were administered.Ems crew was unable to clear the user advisory messages by powering the device off and on.Therefore, they reverted to manual cpr.Manual cpr was performed for 30 minutes on scene until the patient was pronounced dead by the lead paramedic.Return of spontaneous circulation (rosc) was never achieved.Customer believes that the cause of death was due to the cardiac arrest, however exact cause is unknown as no autopsy was performed.Customer does not attribute the patient's death to the autopulse stoppage and indicated that patient had a history of cardiac issues and high blood pressure.No further information was provided.

Manufacturer Narrative

Back at the station, the platform was powered on with nothing on it and both ua 18 and ua 02 were still displayed.The product in complaint was returned to zoll on (b)(6) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform shows that the lcd backlight was not functioning.The physical damage found during visual inspection is not related to the reported event of multiple user advisories (ua's).The damage appears to have been caused by normal wear and tear (autopulse manufactured in march of 2013).A review of the archive was performed and the reported complaint of multiple ua's was confirmed.The archive data shows that multiple user advisory (ua) 2 (compression tracking error) and ua 18 (max take-up revolutions exceeded) faults occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue of multiple ua's could not be reproduced.The platform was tested with known good batteries and a 95% patient test fixture with no faults found.In addition, load cell characterization testing indicated that both load cell modules were functioning within specification.During testing of the platform, it was observed that the insulation layer of the drive train cables and encoder cables were damaged.However, the observed damages are unrelated to the reported complaint.Based on the investigation, the parts that were identified for replacement are the lcd, drive train motor, clutch plate, and the encoder gear box.In summary, the reported complaint of multiple ua's was confirmed based on the archive review but could not be reproduced during functional testing.The root cause for these observed ua2 and ua18 messages in the archive data could not be determined.Per the battery hangtag - advisory codes description and action (pn 12741-001), 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.Per the battery hangtag - advisory codes description and action (pn 12741-001), 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 damages found during visual inspection and during testing are unrelated to the reported complaint.Upon replacement of the lcd and the damaged parts, the platform passed all testing criteria.Customer believes that the cause of death was due to the cardiac arrest, however exact cause is unknown as no autopsy was performed.Customer does not attribute the patient's death to the autopulse stoppage and indicated that patient had a history of cardiac issues and high blood pressure.

• 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: 3771715
• MDR Text Key: 16802830
• Report Number: 3003793491-2014-00207
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2013
• 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: 73 YR
• Patient Weight: 79