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); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 03/07/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Rib fracture, liver lacerations, and hemothorax are expected adverse event for both manual and mechanical cprs.According to 12 different published reports standard manual, cpr complications occur at rates of 33% for rib fracture, 2.40% for liver injury and 2.60 for pneumo-thorax.These rates are comparable to rates with the use of autopulse.Large randomized clinical trials (circ, linc) showed no difference in the event rate for rib fracture between the manual compression arms and the mechanical compression arms.The safety monitoring boards for both studies determined there was no new risks identified and no risk concerns with the trials.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.

Event Description

It was reported that during patient use on a (b)(6) year old male, the autopulse platform (s/n (b)(4)) lost power and interrupted treatment.To troubleshoot the issue, the li-ion batteries were replaced several times with partially charged batteries.There were 5 different batteries (s/n (b)(4)) used.The clinician reported that the autopulse displayed an "overheating" error message (user advisory (ua) code is unknown).It was also reported that the clinicians received a prompt from the autopulse to "check the location of the patient" (ua code unknown).The user determined that the patient's location was fine.The user restarted the autopulse and compressions resumed normally.The patient was moved to an operating room in the hospital, where the doctor noticed a "crackling" sound near the patient's throat and shoulders.A procedure was performed on the patient's throat, however, the surgeons could not remove the blood out from the cannulas and decided to perform a sternotomy.At which time the doctors noticed blood in the chest cavity.The doctor noticed a hole on the heart's back, lower chamber.The patient had a broken rib on their left side, which was determined by the clinician to have made a hole on the heart and cause internal bleeding.The patient expired.No additional information was provided.Reference: 3010617000-2016-00194, 3010617000-2016-00195, 3010617000-2016-00196, 3010617000-2016-00197, 3010617000-2016-00198.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)), and 5 li-ion batteries (s/n (b)(4)) were returned to zoll for evaluation.Investigation results as follows: device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).A visual inspection of the returned autopulse platform was performed and found no physical damage noted upon receipt of the platform.A review of the platform archive log showed "battery lost" and user advisory (ua) 11 (max patient temperature exceeded) messages had occurred on (b)(6) 2016 and not on the reported event date of (b)(6) 20166.During this date, there were 18 "battery lost" incidents recorded.Batteries were either removed when the device was still powered on or the battery lock was not used to secure the battery from popping loose during compressions.The archive also shows there were multiple user advisory 11 occurring on the same event date.The platform is designed to display ua 11 message when the temperature of the patient surface exceeds 45°c (113°f) for more than five minutes by triggering the temperature sensor near the battery bay.The message is informing the user that the ambient temperature is outside of operating parameters.The platform was functionally tested and the autopulse exhibited no user advisory messages.Further testing showed that the temperature sensor was functioning properly.In summary, the customer's reported complaint of autopulse losing power and displaying overheating message was confirmed during archive review but not during functional testing.The potential root cause for the autopulse losing power is either the batteries were removed when the device was still powered on or the battery lock was not used to secure the battery from popping loose during compressions.The reported complaint of the autopulse prompting to check the location of the patient was not confirmed.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.The probable cause for ua 41 message that was observed in the archive is the vents underneath the autopulse were either blocked or the device was stored in a hot environment such as stored in a hot vehicle or exposed to direct sunlight for a period of time.This will increase the internal temperature to the autopulse.Testing shows the temperature sensor is functioning properly.

• 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: 5515388
• MDR Text Key: 40829783
• Report Number: 3010617000-2016-00174
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2007
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR