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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform ((b)(4)) stopping compression was not reproduced during functional testing: however, was confirmed through archive data review.Review of the archive data revealed that on (b)(6) 2018, the platform inserted with an adequately charged autopulse li-ion battery was used on a medium to large sized patient performing compressions then displayed multiple user advisory (ua) 17 (max motor on time exceeded) error messages, thus confirming the reported event.The ua 17 error message was displayed as the driveshaft met resistance due to the stiffness of the patient's chest.Visual inspection of the platform revealed no physical damage upon receipt.The platform was functionally tested using a good known autopulse li-ion battery with a large resuscitation test fixture and no ua 17 error message or any other issue were observed.The platform was further tested and operated as expected without issue.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The 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.During a ua 17 error message, the platform is trying to achieve the 20% compression but did not have enough power to achieve this compression rate within 0.38 seconds.Historical complaints were reviewed for service information related to the reported complaint and there were two similar complaints reported for autopulse platform with serial number (b)(4).(b)(4) reported on (b)(6) 2012 and (b)(4) reported on (b)(6) 2016.The complaints were not confirmed.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 stopped performing compressions on an (b)(6) male patient.The crew reset the band and restarted the device and the device started compressions again but stopped again after a few minutes.The patient was pronounced after the code.There were minimal delays in compressions while the band was reset.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

As reported, during patient use the autopulse platform ((b)(4)) stopped in the middle of compression.The crew immediately troubleshoot and restarted the platform, it stopped compression after a few unspecified minutes.The patient was pronounced after cardiac arrest.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7625812
• MDR Text Key: 112200325
• Report Number: 3010617000-2018-00578
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• 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: 82 YR