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

Model Number MODEL 100

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

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

Event Date 11/18/2014

Event Type  malfunction  

Event Description

The initial call came in on (b)(6) 2014 for a(b)(6) year old unresponsive female patient weighing (b)(6) lbs.The cardiac arrest occurred at the patient's residence.Patient was down for an unknown length of time.Manual cpr was performed by the police department prior to ems arrival (exact length of time was not provided).Upon arrival, ems crew deployed the autopulse platform within a couple of minutes without any issues.The platform performed a couple compressions and then displayed a "realign patient" message.The crew noticed that the lifeband was centered over the patient's abdomen so they realigned the patient on the platform.However, the platform displayed the same "realign patient" message.Customer stated that they correctly centered the lifeband on the patient's chest on the third attempt.The platform then displayed a "pull up lifeband" message.The crew pulled the lifeband completely up but the message did not clear.Cpr was stopped for 15-20 seconds during this time.Customer indicated that the patient was on the living room floor and was not being moved at the time of the "realign patient" messages.After the third attempt to restart the platform, the crew discontinued use of the autopulse and reverted to manual cpr for the duration of the call (exact length of time was not provided) until arrival at the er.The patient was transported to the hospital, which was a mile away.Customer indicated that the patient was not alive upon arrival at the hospital.It is unknown what the course of treatment in the er was.Patient never achieved return of spontaneous circulation (rosc) and died on the same day.The cause of the cardiac arrest and death are unknown.It is unknown if an autopsy was performed.Customer also declined to provide patient medical history or medications.The ems-basic who was on scene could not state whether the patient's death was related to the autopulse.However, he indicated that the patient was already unresponsive prior to ems arrival.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 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 bottom cover was cracked.The physical damage found during visual inspection is not related to the reported complaint of the platform displaying a "realign patient" message.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 01/2009).Review of the autopulse platform's archive was performed and showed that user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) and ua 12 (lifeband not present) messages occurred on the reported event date of (b)(6) 2014.Functional testing was performed using a 95% patient test fixture (large resuscitation test fixture).During testing, the platform stopped compressions multiple times and displayed ua 27 (encoder fault (> 3000 rpm)) messages.It was observed that the encoder was at fault.It was also observed that the encoder was sticky.This fault was found to be due to the clutch plate.Additionally, a load cell characterization test was performed and showed that both load cell modules were functioning within specification.Based on the investigation, the parts identified for replacement were the encoder, clutch plate and the bottom cover.In summary, the reported complaint of the platform displaying a "realign patient" message was confirmed based on the platform's archive review.The fault was found to be due to the patient being out of position or not properly centered, which would trigger the platform to display a ua 7 fault.The root cause for the ua12 fault could be likely due to the user incorrectly centering the lifeband over the patient's abdomen.The ua 27 fault and the sticky encoder found during functional testing are unrelated to the reported complaint.The physical damage found during visual inspection is also unrelated to the reported complaint.Upon replacement of all parts, the platform was re-evaluated through functional testing and 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: 4334761
• MDR Text Key: 16992501
• Report Number: 3010617000-2014-00661
• 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: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2009
• 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: 69 YR
• Patient Weight: 82