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.In this case, the patient's age was (b)(6).Prior to being intubated, the patient had pooled fluid in the back of her throat, blood and clear fluid was also suctioned off of the patient's lungs.It was not clear if patient had pre-existing trauma including a broken rib.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.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 (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 were 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.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 a (b)(6) female patient in cardiac arrest found unconscious and out of breath by her family at home.The patient had a known history of atrial fibrillation and diabetes.It was unknown if a manual cpr was performed by the patient's family.The responding team arrived at the scene after 15-20 minutes and found the patient lying supine at home, pulseless and apnic.Her skin was dry and no rigor mortis.The patient was asystole on the electrocardiogram monitor and had a blood sugar level of 149 mg/dl.Prior to being intubated, the patient had pooled fluid in the back of her throat, blood and clear fluid was also suctioned off of the patient's lungs.The patient was in pulseless electrical activity (pea) after a first dose of epinephrine was administered and remained in pea on subsequent pulse checks.Following these, manual cpr was administered and the patient's oral airway was established.Patient received ventilation through a bag valve mask.The autopulse platform was deployed without any issues.During active operation, the platform was set on continuous compressions inside the ambulance.During transit, intraosseous and intravenous infusions were started and the patient was further administered with two separate doses of epinephrine.The patient never achieved rosc (return of spontaneous circulation).The patient arrived at the hospital approximately four minutes after departing from the scene and was turned over to the emergency department upon arrival with ongoing resuscitation efforts.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: 6413199
• MDR Text Key: 70328540
• Report Number: 3010617000-2017-00203
• 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

• 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
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/17/2017
• 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: 94 YR