MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device associated with this complaint will not be returned for evaluation.Since the device was not returned, a physical investigation of the device could not be performed and a root cause could not be determined.In the case the device is returned, the complaint will be re-opened to perform an investigation.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.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.This patient was found pulseless before manual and autopulse cpr, hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.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 Description

Male patient, approximately 15-20 years old, after the pedestrian-car accident was found lying prone in the middle of the street bleeding profusely from a 5-inch full-thickness laceration to left occipital lobe as well as hematoma and bruising above the right eye.The patient face was covered in blood.The patient also presented with significant bruising to the left rib cage, bleeding, and bruising to chest and arms.The patient was reported to be agonal breathing shortly before ems arrival.The bystander cpr was performed.Upon paramedic's arrival, the patient was found apneic and pulseless.The crew initiated manual cpr while preparing the autopulse platform for approximately 3 minutes and 45 seconds.Bhc initiated due to the traumatic arrest.Due to the pulseless electrical activity (pea) the crew decided to transport the patient to the hospital.Cpr continued by the platform while the crew prepared the patient for transportation.The crew made intraosseous infusion (io) in the patient's left tibia and three rounds of epinephrine injection (epi) were given.Igel was withheld due to significant facial trauma and bls airway was maintained.During patient transport, that lasted around 13 minutes, the platform stopped compressions.Unknown if any user advisories were displayed by the platform.The platform indicated to reposition the patient and reset the lifeband.The crew tried to reposition the patient as they could with the spinal precautions in place, however, the issue could not be resolved.Immediately the crew reverted to manual cpr for an unknown period of time.Upon arrival at the hospital, the patient was asystole on the monitor.The patient was pronounced in the hospital.Per the reporter, the patient's outcome is not related to the autopulse platform.The platform was tested following day with the manikin and worked as designed without any problems and will not be returned for evaluation.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10382978
• MDR Text Key: 202201562
• Report Number: 3010617000-2020-00763
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1