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 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.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, autopulse compressed for about 6 minutes.Manual cpr was performed before autopulse deployment for 14 minutes and after the platform stopped working for approximately 30 minutes.Rosc was not achieved by the combination of mechanical cpr and manual cpr.The transition from autopulse to manual cpr by trained users is quick and similar to the time necessary for rescuer rotation, presenting the same workflow as manual cpr only.Hence, because the conversion to manual cpr is quick and is always available, the patients' outcome is not negatively impacted by the transition when compared to standard of care manual cpr.The cause of patient's death was likely to be patient's underlying clinical condition.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, death is attributed to ohca.Death is an expected outcome for ohca.

Event Description

As reported during a call on (b)(6) 2017, the autopulse platform (sn: (b)(4)) was used on (b)(6) male patient that weighted around (b)(6) that was experiencing cardiac arrest.The crew performed 14 minutes of manual cpr before initiation of the platform.The autopulse platform was deployed and 6 minutes into the therapy, the platform stopped working and red fault light came on; however, it did not power off.The platform did not display any error message.The crew then performed manual cpr for approximately 30 minutes.Rosc (return of spontaneous circulation) was not achieved.(b)(6) corner pronounced the patient death.The cause of the cardiac arrest is unknown.Customer does not attribute the patient's death to the use of the autopulse platform.On multiple occasions, the customer had run the autopulse through many scenarios and it never failed to perform compressions in the controlled setting using a manikin.Upon following up for (b)(4) for platform with serial number (b)(4), two additional patient events were reported.(b)(4) were created for the events.This is 3 of 3 events.3010617000-2017-00501 = (b)(4), 3010617000-2017-00567 = (b)(4).

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was not returned for evaluation; therefore visual and functional testing was not performed.The customer reported complaint for the autopulse platform stopped working and displaying a fail (red) led without any error message was not confirmed during archive review; however on the reported event date error message user advisory 18 (max take-up revolutions exceeded occurred during takeup) was noted.Since the platform has not been returned, physical investigation could not be performed.Therefore, a root cause could not be determined.The archive data review indicated that on the customer reported date of 06/08/2017, the platform was powered on and an error message user advisory (ua) 18 displayed for a duration of 9 seconds and no cycle of compression was initiated before powering off.The user pressed the start button and the drive shaft moved the lifeband past the maximum allowable takeup depth without detecting a patient.The platform has detected that either the patient's chest is too small while sizing the patient (take up) or that no patient on the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for autopulse sn (b)(4).Referenced mfr reports: 3010617000-2017-00501 = (b)(6) autpulse platform 3010617000-2017-00567 = (b)(6) autopulse platform.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6777852
• MDR Text Key: 82810554
• Report Number: 3010617000-2017-00568
• 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
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2010
• 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
• Patient Weight: 82