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

Model Number MODEL 100

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Death (1802); Fall (1848)

Event Date 04/18/2015

Event Type  malfunction  

Event Description

It was reported that an initial call came in for a (b)(6) year old male patient who had fallen.Patient weighed (b)(6) kg.Patient's medical history is unknown.Patient was working in his backyard and was found by a family member.The family member initiated manual cpr (exact length of time was not provided).However, the patient's condition did not change.It is unknown how long the patient was down for prior to manual cpr.The fire department were the first responders on scene and took over manual cpr upon arrival.In addition, they placed a monitor on the patient.Patient was asystole and unresponsive.No shocks were advised.Next, the ambulance arrived on scene within 6 minutes.The autopulse platform was deployed without any issues.Patient was intubated.An iv was started and patient was given medication.The platform performed compressions for an unknown length of time.The crew then paused the platform to check the patient's pulse.When they restarted the platform, it displayed a user advisory (ua) 19 (max applied load exceeded) message.Customer indicated that there was no patient movement at this time.The crew powered the device off then back on but the message did not clear.Use of the autopulse was discontinued and the crew reverted to manual cpr.Patient was extricated via a longboard to a stretcher and was taken to the hospital 20 minutes after ems arrival.Transport time to the hospital was 7 minutes.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead by the hospital physician on the same day.It is unknown if an autopsy was performed.The cause of cardiac arrest and death are unknown.However, the customer does not attribute the patient's death to the autopulse.

Manufacturer Narrative

Customer also indicated that after the reported patient event, the platform was tested with a mannequin and displayed the same user advisory 19 message.The autopulse platform in complaint was returned to zoll on 04/29/2015 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 was performed and no damages were observed.Functional testing was performed and the reported complaint of the platform displaying a user advisory (ua) 19 (max applied load exceeded) could not be duplicated.Compression testing was performed using a large resuscitation test fixture for several hours with no user advisories, system errors or warnings exhibited.Load cell characterization was performed which confirmed that both load cell modules were functioning within specification.A brake gap inspection was also performed, which verified that the brake gap was within the specification of 0.008" ±0.001".During device inspection, there were no deficiencies identified which may have caused or contributed to the reported ua 19 codes occurring.A review of the platform's archive data was performed.Contrary to the reported event information provided, the platform archive showed no compressions being performed on the reported event date of (b)(6) 2015.However, the archive does show that on (b)(6) 2015, multiple ua 19 codes occurred.The data indicates that, at the time the ua 19 codes were displayed, the platform was used repeatedly to provide compressions on a very large, stiff and hard to compress patient.The maximum load force measured on the platform at this time exceeded 270 lbs.Based on the investigation, no parts were identified for replacement.During functional evaluation, a sticky encoder shaft symptom was observed.In order to remedy this issue, the clutch plate was de-burred to remove the sharp edges from all 12 hex edges of the armature plate.In summary, the reported complaint of the platform displaying ua 19 codes was confirmed through platform archive review.The archive data shows that multiple ua 19 codes occurred on (b)(6) 2015, rather than on the reported event date of (b)(6) 2015.The data indicates that, at the time the ua 19 codes were displayed, the platform was being used repeatedly to compress a very large, stiff and hard to compress patient.The maximum load force measured on the platform while it was in use exceeded 270 lbs.During evaluation of the platform, there were no device deficiencies found that may have caused or contributed to the reported event.Based on the device evaluation, there is also no indication the autopulse platform caused or contributed to the reported patient outcome.The cause of cardiac arrest and death are unknown.However, the information received indicates that the customer does not attribute the patient's death to the autopulse.Following service, the platform passed all functional test 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: 4776363
• MDR Text Key: 5778835
• Report Number: 3010617000-2015-00274
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2008
• 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: 59 YR
• Patient Weight: 70