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 Contusion (1787)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

The reported complaint of cracked covers on the autopulse platform (serial #(b)(4)) was confirmed during visual inspection.The bottom cover has multiple cracked at the screw well areas (screws mount to the top cover) and cracked front cover at the front end area of the platform.The probable root causes of the damaged covers was due to wear and tear.The autopulse platform was manufactured in march 2016 and is nearing its serviceable life of 5 years.The damaged covers needs to be replaced.The reported cracked sound and blue dust appeared could not be duplicated during functional testing but could be possibly related to the cracked/broken covers that was heard and observed by the customer.Unrelated to the reported complaint, the encoder drive shaft on the returned autopulse platform does not rotate smoothly, exhibits binding and resistance due to sticky clutch, likely attributed to wear and tear.Deburring of the sticky clutch to remedy this issue.During archive data review, user advisory ua45 (not at "home" position after power-on/restart), ua2 (compression tracking error) and ua12 (lifeband not present) were recorded on the reported event date.These uas could be possibly be related to the reported cracked covers.Per the autopulse resuscitation system model 100 user guide, error messages recorded in the archive data is easily clearable by the user.The ua45 will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.The lifeband strap was not pulled completely out prior to turning the device on.The ua2 (compression tracking error) occurred on the first compression.This typically occurs if the patient is misaligned on the platform or the lifeband is opened.The ua12 (lifeband not present) error message alerts the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.Awaiting customer's approval on the service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial #(b)(4).Event death: the patient's death was not related to the autopulse device.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) 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 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.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 skin bruise marks: chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) 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, "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.Based on available information, the event of skin bruise marks was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin bruise marks location and the time point, the event of skin bruise marks was probably related to the autopulse device.In the same time, the patient is obese, and the oversize body with very tight lifeband also can cause skin bruise.

Event Description

Customer reported that the autopulse platform (serial #(b)(4)) made a cracked sound while performing compression on the patient and observed blue dust appearing on a hospital's bed.Patient had bruise marks (in line with the lifeband) at the same area where the location of crack.When patient was removed, crew noticed cracked covers.At the fire station, the crew noticed all the mounting screws were loose on the bottom of the autopulse platform but it still function as normal.Patient was (b)(6) years old, (b)(6) lbs and she was pronounced at the hospital.Per reporter, the autopulse was at no fault or did not attributed to the patient outcome.

Manufacturer Narrative

During archive data review, user advisory ua45 (not at "home" position after power-on/restart), ua2 (compression tracking error) and ua12 (lifeband not present) were recorded on the reported event date.These uas are not related to the reported cracked covers.After service repair 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 ap platform passed all functional tests.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10274519
• MDR Text Key: 198868362
• Report Number: 3010617000-2020-00674
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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?: Yes
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 104