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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform however, the investigation is pending.A follow-up report will be submitted when the investigation has been completed.Based on 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, during patient use, the autopulse platform (serial #(b)(4)) powered down and would not restart in the emergency department.Hospital staff performed manual cpr.The patient did not achieve rosc and expired in the hospital.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.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) powered down and would not restart in the emergency department.Hospital staff performed manual cpr.The patient did not achieve rosc and expired in the hospital.

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4) powered off while being use on a patient was not confirmed during initial functional testing but confirmed in the archive data review.The investigation findings revealed that during the date of the event, there were two incidents of the device powered off during active operation; one time due to battery lost and the other was a battery saving time out.The battery was not returned for investigation.Hence, the returned autopulse platform performed as intended.During visual inspection, there no physical damage was observed on the returned autopulse platform.During archive data review, user advisory (ua)19 (max applied load exceeded) and ua17 (max motor on time exceeded) was observed.However, these user advisories messages are unrelated to the reported complaint and clearable by the user.User advisory 19 is a common error when the patient gets "bouncy" or the device has detected too much weight being applied during testing and user advisory 17 is an indication that the platform did not reach its target depths within specification.Based on the analysis of the archive data retrieved from the platform, the issue is likely attributed to the stiffness of the patient's chest, a twisted lifeband, and/or the length of time the platform was used performing continuous compression.The returned autopulse platform 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.Based on 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.

• 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: 9526703
• MDR Text Key: 179286309
• Report Number: 3010617000-2019-01134
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: 01/16/2020

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1