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 05/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "when the autopulse was powered on, the platform failed to perform compressions and displayed user advisory (ua) 12 (lifeband not present) error message" was confirmed based on the archive data review but not confirmed during the functional testing.No device malfunction was found during the testing, and the platform functioned as intended.The probable root cause for the reported complaint was due to the belt clip not detected in spool shaft and/or not fully inserted when the autopulse was powered on, most likely attributed to user error.During visual inspection of the returned platform, the front-end area of the front enclosure was observed cracked, unrelated to the reported complaint.The root cause for the observed physical damage could be due to user mishandling.Front enclosure was replaced to address the issue.A review of the autopulse platform archive was performed, and it showed ua12 (lifeband not present) error message to have occurred on the customer's reported event date; thus, confirming the reported complaint.Based on the archive, when the autopulse was powered on, the platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message and then, the autopulse powered off, unrelated to the reported complaint.The user pressed restart to clear the error message.When the autopulse was powered back on, the platform displayed the ua07 error message again.The archive shows that the platform was repeatedly re-started several more times, and each time, the device was powered back on with ua07.Eventually, when the user restarted the autopulse, the platform was powered back on with ua12, and then, the use of the autopulse platform was discontinued.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide, user advisory (ua) 07 is an indication that the patient out of position or the patient is not properly centered.Per the battery hangtag - advisory codes description and action, user advisory (ua) 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.The autopulse platform passed initial functional testing without any fault or error, and the reported complaint of ua12 error message could not be replicated.The lifeband clip detect switch inspection was performed and verified that the belt clip switch lever was able to close and was in a parallel position to the belt clip switch case.In addition, the two screws that hold the switch lever parallel to the switch case were inspected, and it was confirmed that the screws were not missing, and they were properly tightened.During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.The load cell characterization test confirmed that there was no malfunction on the load cells, and both cell modules were functioning within the specification.The root cause for the ua07 observed in the archive was possibly due to the patient not aligned properly on the autopulse platform, attributed to user error.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause for this issue is most likely due to sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The sticky clutch plate was deburred to address the issue.Following 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.The brake gap inspection was performed and verified the brake gap was within the specification.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 to resuscitate a (b)(6) old male patient in cardiac arrest.The cardiac arrest was witnessed by the patient's wife, and the cause was presumed cardiac.Bystander cpr was not performed, and the patient was in cardiac arrest for approximately 8 minutes prior to the ems arrival.When the autopulse was powered on, the platform failed to perform compressions and displayed user advisory (ua) 12 (lifeband not present) error message.As reported, the ems crew did not attempt to clear the error message and immediately performed manual cpr for 24 minutes.However, return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead on the scene.As per the customer, it is unknown if the patient's death was related to the autopulse system.

• 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: 10160698
• MDR Text Key: 195426507
• Report Number: 3010617000-2020-00601
• 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: 06/16/2020

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: 06/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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 Age: 73 YR
• Patient Weight: 127