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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Manufacturer Narrative

The primary reported complaint of the autopulse platform (sn (b)(4)) stopped compression was confirmed during archive data review.The root cause was due to a defective autopulse li-ion battery (sn (b)(4)) due to a damaged temperature sensor on the battery management board most likely caused by a mechanical impact.The secondary reported complaint of the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed during functional testing and archive review.The root cause for the ua45 error was due to drive shaft not being at "home position".The ua45 error message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.However, in this case, noticed that the encoder drive shaft was stuck and cannot be rotated due to the normal wear and tear of the platform.This might have caused the difficulty for the user to pull up the lifeband completely prior to turning the device on.The tertiary reported complaint of the platform displayed ua 2 (compression tracking error) was confirmed during archive data review.Ua 2 occurred when the platform was tilted during compression.The root cause was due to user error.Note that the user advisory error messages are designed into the platform when one of several conditions is detected.Ua 2 alerts the operator that 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 user advisory will persist until the patient is properly aligned.Per the autopulse user guide instruction, to clear the error message, the operator needs to pull up the lifeband until the chest bands are fully extended.During visual inspection, no physical damage was observed.The archive data review revealed that, the platform power off three times due to defective battery (sn (b)(4)).In addition, multiple ua 45 error message and ua 2 error message were observed.During functional testing, the autopulse platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message" upon powering on.The clutch plate was deburred, and the drive shaft was rotated to home position to clear the ua45 error message.After clearing the ua45 error message, the autopulse platform performed compressions without any fault or error using lrtf (large resuscitation test fixture).Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with sn (b)(4).Per zoll medical safety assessment, 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.In this case, the autopulse platform (sn (b)(4)) was used on a cardiac arrest patient and the platform initiated compressions successfully.However, the platform stopped compression when the tarp was pulled down.The crew immediately performed manual cpr while troubleshooting the observed issue.The autopulse platform resumed the compressions for few minutes and stopped again after removing and re-inserting the autopulse li-ion battery (sn 48547).The crew resumed manual cpr for the rest of the call.A return of spontaneous circulation (rosc) was not achieved.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.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

The autopulse platform (sn (b)(4)) was used on a cardiac arrest patient and the platform initiated compressions successfully.However, the platform stopped compression when the tarp was pulled down.The crew immediately performed manual cpr while troubleshooting the observed issue.The crew noticed that the tarp caught the lifeband clip and resulted in the lifeband to get dislodged.The autopulse platform resumed the compressions for few minutes and stopped again after removing and re-inserting the autopulse li-ion battery (sn (b)(4)).The crew resumed manual cpr for the rest of the call.A return of spontaneous circulation (rosc) was not achieved.The platform failure did not affect the patient treatment as manual cpr was initiated.After the call, the crew attempted to troubleshoot by inserting a new lifeband, however, upon power up, the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.Back at the station, the user had difficulty in removing the battery from the platform.After the battery was removed, the battery status indicator illuminated 4 green led.Upon re-inserting the battery, the platform powered on and displayed ua 45.The user was able to clear the ua 45 by rotating the driveshaft to the home position.During testing with a manikin, the platform powered off on its own.The user replaced the battery and the platform performed compressions.During compression, the platform was tilted and displayed ua 2 (compression tracking error) followed by ua 45.No further testing was performed by the user.Mfr 3010617000-2020-00803 references the autopulse li-ion battery (sn (b)(4)) used in this event.

• 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: 10440268
• MDR Text Key: 204569953
• Report Number: 3010617000-2020-00804
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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