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 Problems Bone Fracture(s) (1870); Pneumothorax (2012)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Visual inspection was performed and noted no damage upon receipt.Initial functional testing was performed and passed with no error message.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The brake gap inspection was performed and verified the brake gap was within the specification.Review of the archive data indicated user advisory (ua) 02 (compression tracking error) occurred on the first compression.The autopulse was powered on and had four sessions (624, 72, 554 and 0 compressions) with a duration of 25 minutes and 13 seconds for a total of 1250 compressions.Platform generated a user advisory (ua) 01 (low battery warning) and was powered off by the user.The platform was powered on again and showed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart), and again, it was powered off by the user.The platform was power on and off 8 times with user advisory (ua) 45 error.Archive data show the user was able to clear the user advisory (ua) 45 error by returning the drive shaft to home position.Following this, the platform was used for two more sessions (407 and 461 compressions) and displayed user advisory (ua) 12 (lifeband not detected).The platform was power off by the user.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The user advisory (ua) 02 error message alerts the operator as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.This typically occurs if the patient is misaligned on the platform or the lifeband is opened or in the incorrect position during take up/compression.The user advisory (ua) 01 error message alerts the user that the battery being used is running low.The user advisory (ua) 45 informs the customer that the drive shaft was not at "home" position when the platform was powered on.(ua) 45 is the clearable error message and are designed into the platform to alert the operator that autopulse has detected one of several conditions.The user advisory (ua) 12 error message is easily clearable by the user.The user advisory (ua) 12 error message alerts the operator that the lifeband clip is not properly engaging the safety switches in the driveshaft.The user advisory (ua) 12 error message can be cleared by ensuring that the lifeband is properly installed and subsequently restarting the platform.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for autopulse sn 33597.The fractures (rib fractures) are expected adverse event for both manual and mechanical cprs.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 was 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 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.In this case, the autopulse platform (sn (b)(4)) was used in cardiac arrest patient for 30 minutes compressions.The patient did achieve the rosc at the hospital after received both autopulse cpr and manual cpr, however, was pronounced a few hours later.There was a large air pocket found on the patient's left thorax and broken ribs on the same side.It was unknown if there was any injury during the way to transport the patient to hospital.Rib fracture can be caused by manual cpr as well as with the mechanical cpr.However in the same time the connection of the reported injury to using autopulse cannot be ruled out.Based on available information, the event of "a large air pocket found on left thorax and broken ribs" was possibly related to the autopulse device.The patient's death was not related to the autopulse device.In this case, the autopulse platform (sn 33597) was used in cardiac arrest patient for 30 minutes compressions.The patient did achieve the rosc at the hospital after received both autopulse cpr and manual cpr, however, was pronounced a few hours later.There was a large air pocket found on the patient's left thorax and broken ribs on the same side.It was unknown if there was any injury during the way to transport the patient to hospital.Base on available information, the patient had been in cardiac arrest before autopulse platform (sn (b)(4)) was used.Rosc was achieved after received both autopulse cpr and 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 ((b)(4) 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

The autopulse platform (sn (b)(4)) was deployed without issue on a (b)(6) years old male patient who had been in cardiac arrest, witnessed.Aed was placed in service and did not advise the shock.The platform performed continuous compressions for at least 30 minutes during the entire call.No patient trauma or a fall prior to the autopulse use and it is unknown if there was any movement of the patient on board during the transport.Per additional information received from the customer, if there was any physical compromise to the patient, it was caused by the autopulse.Reported later by hospital personnel, the patient did achieve the rosc at the hospital, however, was pronounced a few hours later.In addition, there was a presence of the large air pocket on the left side of the patient's thorax and broken ribs on the same side.Per reporter, it is unknown if the patient achieved rosc from the autopulse cpr or from manual cpr at the hospital.However, the air pocket had been observed at arrival to the hospital.

• 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 8096707
• MDR Text Key: 128314088
• Report Number: 3010617000-2018-01185
• 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: 11/21/2018

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: 11/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• 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: 62 YR