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 Death (1802)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (sn (b)(4) was returned to zoll on (b)(6) 2020 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.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.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 an (b)(6) year old female in cardiac arrest.The platform did not perform compression and displayed an unknown error message.The crew immediately performed manual cpr.A return of spontaneous circulation (rosc) was not achieved.The patient was pronounced deceased.In addition, the user washed the platform with a regular hose and disinfected as the platform had bodily fluids.Per user, the patient's outcome was not related to the autopulse platform.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) did not perform compression and displayed an unknown error message was not confirmed during functional testing; however, was confirmed during archive data review.Based on the archive review, the autopulse platform stopped and displayed user advisory (ua) 20 (position out of range) and ua 12 (lifeband not present).The root cause of the ua 20 was due to the patient chest circumference was very small in size and the root cause for ua 12 was due to no lifeband was installed or not properly installed.No device malfunction was observed during the testing and the platform worked as intended.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Ua 20 error message alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.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.This action will move the driveshaft to its home position.Visual inspection was performed and found cracked front cover at the front-end area.Root case was due user mishandling such as a drop.This observation is unrelated to the reported complaint.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 platform passed all functional tests and is ready for clinical use.During archive review, 2 occasions of ua 20 and multiple ua 12 were observed on the reported event date.Thus, confirming the reported complaint.The root cause of the ua 20 was due to the patient chest circumference was very small in size and the root cause for ua 12 was due to no lifeband was installed or not properly installed.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10564731
• MDR Text Key: 212505064
• Report Number: 3010617000-2020-00943
• 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: 10/15/2020

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: 09/11/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR