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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

There were no device deficiencies found during evaluation of the autopulse platform (sn (b)(4)).The platform was functionally tested and passed all functional testing criteria including the load characterization check.The platform operated using a light resuscitation test fixture with continuous compression without error and met all required specifications.Review of the archive data retrieved from the platform found no functional issue.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).The event is possibly related to the autopulse device.Rib fracture is an 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.These rates are comparable to rates with the use of autopulse.Large randomized clinical trials ((b)(4)) 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.In this case, the patient was an (b)(4) female.Both manual cpr and mechanical cpr were performed.The timing and location of the injury cannot rule out the device as a cause, however, other factors (pre-existing trauma, manual cpr, etc.) may have caused or contributed the injury.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.The death was not related to the device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.According to the reporter, the autopulse provided compression as intend for use.Rosc was not achieved by a combination of manual cpr and mechanical cpr, and other bls and als protocols.The cause of death is likely to be the patient's underlying clinical condition.Death is an expected outcome for ohca.The autopulse platform is a reusable device and was manufactured in 22 jun 2016.

Event Description

On (b)(6) 2017 the emergency medical services (ems) crew responded to an (b)(6) female patient in cardiac arrest.The cardiac arrest was witnessed by a family member.She fell/collapsed and had been unresponsive.The patient had complained of not feeling well and had stated that she might've eaten some bad food the previous day.According to the patient's family, the patient was a do not resuscitate (dnr); however, the family was not able to provide the document.It was unknown if a manual cpr was performed by the patient's family.The responding team arrived at the scene after 8-10 minutes and found the patient lying supine and pulseless.The ems crew administered manual cpr for an unspecified time and applied fast patches.The patient was in pulseless electrical activity (pea).Patient was ventilated with a bag valve mask.Intraosseous (io) infusion was administered; however, patient remained pea.The autopulse platform was deployed without any issues.During active operation, the platform was set on continuous compressions.The patient was moved inside the ambulance.During transit, a dose of epinephrine was administered via io and the patient was ventilated through a device placed in the supraglottic airway and a capnographer with a bag valve mask.Patient remained in pea and a second dose of epinephrine was administered.Autopulse cpr remained ongoing.During transit, the responding team stated that the patient had agonal respirations but no palpable pulse present.Patient still in pea and a third dose of epinephrine was administered.The platform performed continuous compressions throughout the transport.The patient never achieved rosc (return of spontaneous circulation).The patient arrived at the hospital approximately eight minutes after departing from the scene and was turned over to the doctor upon arrival.The patient was pronounced in the hospital's emergency department.It was further reported that the patient sustained a broken rib injury.No functional issue was reported on the autopulse platform.No further information provided.

• 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: 6413795
• MDR Text Key: 70358443
• Report Number: 3010617000-2017-00204
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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
• Patient Age: 81 YR