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

Model Number MODEL 100

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

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Internal Organ Perforation (1987); Multiple Fractures (4519)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Based on archive data review on the reported event date of (b)(6) 2020, the autopulse platform (sn (b)(4) performed as intended.No user advisory (ua) or system error messages was observed.During investigation on (b)(6) 2020, the autopulse platform, the platform displayed user advisory (ua) 41 (patient temperature sensor failure) upon power up.Following this, the platform was restarted a few times, and ua 41 was cleared.The platform was tested with the large resuscitation test fixture (lrtf) equivalent to 280 lbs.With good known test batteries until discharged without any fault or error.As a precautionary measure, the temperature sensor was replaced.The root cause of the defective temperature sensor in which is likely attributed to normal wear and tear.The autopulse platform was manufactured in 29 september 2020 and has a serviceable life of 5 years.This observation is not related to the reported complaint.After service completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.Per medical safety assessment, chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skin damage, common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax, diaphragmatic injury) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "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 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." rib fracture can be caused by manual cpr as well as with the mechanical cpr.The event was probably related to the device since the connection of the reported injury to the device cannot be ruled out.Perforation of diaphragm can be caused by manual cpr as well as with the mechanical cpr.The event was probably related to the device since the connection of the reported injury to the device cannot be ruled out.Splenic laceration/subcapsular hemorrhage can be caused by manual cpr as well as with the mechanical cpr.The event was probably related to the device since the connection of the reported injury to the device cannot be ruled out.The patient's death was not related to the autopulse device.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

After the autopulse platform (sn (b)(4) was used on a female patient on cardiac arrest and was transported to (b)(6) hospital for further care.The platform functioned as intended and no malfunction of the platform was reported.During the call, the crew initiated manual cpr and followed with the autopulse platform (sn (b)(4) on a (b)(6) year old female patient on cardiac arrest.The patient was intubated and defibrillated multiple times, including double sequential defibrillation.Total time of resuscitation was approximately 60 minutes.Manual cpr was administered prior to transport from 00:53 to 01:18 and autopulse platform started from 01:18 till 01:52.Rosc (return of spontaneous circulation) was achieved and was transferred to the hospital.The patient arrived with pulse.However, the hospital staff reported that the patient expired.It was reported that the patient had traumatic injuries based on further imaging.It was found that the patient have acute fractures on the left second through eight rib, acute fractures on the second through seventh ribs, splenic laceration/subcapsular hemorrhage and perforation of diaphragm.Finally, dnr (do not resuscitate) was made by patient's family due to multisystem organ failure and risk of subsequent cardiac arrest, and the patient expired in hospital.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 10624437
• MDR Text Key: 209803188
• Report Number: 3010617000-2020-01039
• 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: 10/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2020
• 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: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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: 72 YR