MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

The zoll autopulse platform was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.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, autopulse did not restart compression after it was paused to check patient status.After changing the lifeband, the compression was performed ok.The crew reverted to manual cpr when autopulse did not restart again after being paused.For a trained user, changing lifeband, and changing from the autopulse to manual cpr can be made quickly, and is similar to the time necessary for rescuer rotation, presenting the same workflow as manual cpr.The patient's outcome should not be negatively impacted when compared to standard of care manual cpr.The patient was not revived by the combination of mechanical and manual cpr.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).In this event, patient's arrest was not witness, and the down time may have been as long as 2 hours.Death is attributed to ohca.Death is an expected outcome for ohca.

Event Description

During patient use on a (b)(6) year old female patient treated for post cardiac arrest, autopulse platform was paused after 10-12 minutes for a first rhythm check of the patient and could not restart by pressing the green button to continue.Autopulse platform generated an unknown user advisory error requesting to pull up the lifeband.The customer tried to clear the error message without success.The platform was removed from under the patient and manual cpr was immediately started for approximately 5 minutes.Lifeband was replaced and autopulse platform start performing compressions again without issues.After unspecified time, autopulse platform powered down and restarted and stopped performing compressions.Following this, manual cpr was immediately performed for another 5-10 more minutes; however, a return of spontaneous circulation was not achieved and the patient died.The customer does not attribute the patient's death to the use of the platform.

Manufacturer Narrative

The customer complaint of stopped compression was confirmed during archive data review of the returned autopulse platform (sn: (b)(4)).The stopped compressions were due to user advisory 17 (max motor on time exceeded).However, the reported issue could not be reproduced during functional testing.Since the issue could not be replicated and no device deficiencies were found that could have caused or contribute to the reported issue, the root cause of the customer complaint could not be conclusively determined.In addition, unrelated to the customer complaint, front cover was observed to be cracked during visual inspection and the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.Base on the archive, during the deployment date of (b)(6) a fully charged li-ion battery s/n (b)(4) was used.The autopulse platform performed 791 compressions over a period of nine minute and twenty nine seconds on a regular size patient.The autopulse platform stopped compressing due to user advisory 17 - (max motor on time exceeded).After the user re-started autopulse platform to clear the fault, the platform continue to be used again with the same battery and stop compressing four more times with user advisory 17.After front cover was replaced, clutch plate was deburred and drive train motor brake gap inspection was performed and verified within the specification.After repair, a run-in test was performed using the 95% patient large resuscitation test fixture (lrtf) using known good test batteries until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number (b)(4).(b)(4), reported on 23/dec/2013.No problem was found, the platform function as intended.It was due to the user error because the platform was used with a patient beyond the recommended size parameters.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7153343
• MDR Text Key: 96117286
• Report Number: 3010617000-2017-01190
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: 01/23/2018

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR