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

Model Number	MODEL 100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoll autopuls platform in complaint will not be returned for investigation.A supplemental report will be filed if the product is returned and investigation has been completed.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.In this case, the autopulse platform was used on (b)(6) years old male with cardiac arrest due to pulmonary embolism during the transport to the hospital.The manual cpr was performed by the responding agency for an unknown length of time prior to use of autopulse.The platform performed compressions between 90 and 120 minutes during the patient transport (100 km) to the hospital.The rosc was not achieved and the patient expired.The ct scan confirmed the cause of the death was a pulmonary embolism.During the patient autopsy, the aortic b-dissection was discovered.Based on available information, the event of pulmonary embolism and aortic b-dissection were the preexisting medical conditions.The patients' outcome was not negatively impacted by performing compressions through autopulse.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.
Event or Problem Description
A (b)(6) years old male went into cardiac arrest due to pulmonary embolism.The manual cpr was performed by the responding agency for an unknown length of time prior to use of autopulse.The platform performed compressions between 90 and 120 minutes during the patient transport (100 km) to the hospital.The rosc was not achieved and the patient expired.The ct scan confirmed the cause of the death was a pulmonary embolism.During the patient autopsy, the aortic b-dissection was discovered.The information related to the preexisting medical conditions of the patient was not provided.According to the doctor, the patient death was not attributed to the device.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8533515
• Report Number: 3010617000-2019-00311
• Device Sequence Number: 1278300
• Product Code: DRM
• UDI-Device Identifier: 00849111000178
• UDI-Public: 00849111000178
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-20
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR