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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of autopulse platform (sn (b)(4)) platform stopped compressions and displayed user advisory (ua) 02 (compression tracking error) error message was confirmed during archive review but not during functional testing.Additionally, customer reported user advisory (ua) 17 (max motor on time exceeded during active operation) error message was confirmed during functional testing and archive review.The defective motor controller board was replaced to remedy the fault.Further testing of the platform indicated that the drive train motor brake gap was within specification, however, during data capture of the depth compression, the platform stopped compressions due to user advisory (ua) 17.No physical damage was observed during visual inspection.Unrelated to the customer complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.Sticky clutch plate was deburred to address the issue.Based on the platform's archive, li-ion battery (sn (b)(4)) with 1273 mah remaining capacity was used.The autopulse platform performed 600 compressions on the medium size patient.The autopulse stopped compressing due to user advisory (ua) 17.After the user re-started the platform to clear the fault, the autopulse continue to be used again with the same battery and stopped after 7 compressions due to the user advisory (ua) 02 error.After the user re-started to clear the fault, the autopulse continue to be used again with the same battery and stop compressing 7 more times with user advisory (ua) 17 and four more times due to user advisory (ua) 02 error during the period of thirteen minutes.Advisory (ua) 02 error message alerts the operator 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 typically occurs if the patient is misaligned on the platform or the lifeband is opened or in the incorrect position during take up/compression.The load cell characterization test confirmed both load cell modules are functioning within the specification.Following the service and repair, the platform was tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient with a good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse serial number (b)(4).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)) performed continuous compressions for approximately 15 minutes and then stopped compressions and displayed user advisory (ua) 02 (compression tracking error) error message.After one try to troubleshoot with unsuccessful, manual cpr was immediately performed for several minutes until lucas automatic device arrived on scene.Lucas automatic device was used for an additional 15 minutes; however, return of spontaneous circulation (rosc) was not achieved and patient was pronounced on the scene.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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

The autopulse platform (sn (b)(4)) was used on the (b)(6) male patient in cardiac arrest and performed continuous compressions.After approximately 15 minutes of use, platform stopped compressions and displayed user advisory (ua) 02 (compression tracking error) message.The customer attempted to troubleshoot the reported problem by readjusting the lifeband.The platform reportedly operated with just 3 to 4 compressions and stopped again with user advisory (ua) 17 (max motor on time exceeded during active operation) error message.Manual cpr was immediately performed for several minutes until lucas automatic device arrived on scene.Lucas automatic device was used for an additional 15 minutes; however, return of spontaneous circulation (rosc) was not achieved and patient was pronounced on the scene.

Manufacturer Narrative

Device manufacture date changed from 03/30/2006 to 07/08/2016.

• 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: 7590020
• MDR Text Key: 110704753
• Report Number: 3010617000-2018-00642
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 06/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR