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 07/27/2017

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.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, manual cpr was performed before autopulse deployment by bystander and by paramedics for an unknown period of time.Autopulse stopped after 2 compressions, and this issue was not resolved by restarting the platform.Manual cpr was immediately performed for an unspecified amount of time while the patient was being transported to the hospital.For a trained user, restarting the platform and changing from the autopulse to manual cpr can be made quickly, and is similar to the time necessary for rescuer rotation.Because the conversion to manual cpr is quick and available, the patient's outcome is not negatively impacted by the transition when compared to standard of care manual cpr.Rosc was achieved after 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).Death is an expected outcome for ohca.

Event Description

It was reported that the emergency crew arrived on the scene responding to a patient in asystole.Per report, prior to the emergency crew's arrival, the patient received bystander cpr, the paramedic arrived and performed an electrocardiogram (ecg) on an automated external defibrillator (where it was indicated that the patient was still in asystole), and administered manual cpr following the ecg.The emergency crew, upon arrival, deployed the autopulse platform (sn (b)(4)) without issue and used it on a patient.After performing two compressions, the platform stopped.The platform was restarted; however, this did not resolve the issue.Manual cpr was immediately performed for an unspecified amount of time while the patient was being transported to the hospital.A return of spontaneous circulation was not achieved, the patient was pronounced at the hospital.The cause of death was unknown.Additional information stated that no issue was observed during shift check, prior to the call.No further information was provided at this time.

Manufacturer Narrative

The reported event could not be reproduced during evaluation of the autopulse platform (sn (b)(4)); however, review of the archive data revealed that on the customer reported event date of (b)(6) 2017, the platform inserted with an adequately charged autopulse li-ion battery (sn (b)(4)) was used on a small sized patient.The platform performed 2 compressions and displayed a user advisory ua 17 (max motor on time exceeded) error message.The user was unable to resolve the issue after restarting the platform.This confirms the customer reported event.Additionally, on (b)(6) 2017, the archive data also recorded that the platform was used using the same battery and performed continuous compression without any error message observed.This indicates that the ua 17 observed on (b)(6) 2017 was cleared.A likely root cause for the ua 17 error message is attributed to user error.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The error message observed in the archive is easily clearable by user.For example ua 17 error message alerts the operator that either the lifeband is twisted or battery voltage is low.This user advisory will persist until the issue is resolved.Per the autopulse user guide instruction, to clear the ua 17 error message, the operator needs to ensure that the lifeband is properly installed and insert a fully charged battery in the platform; and restarting the device.The autopulse platform is a reusable device and was manufactured on 24 sep 2009.It has exceeded its expected service life of 5 years.Evaluation of the platform found no issue.The platform operated using a large resuscitation test fixture without error and met all required specifications including the load characterization check.As part of routine service during testing, the platform was examined and found that the drive shaft exhibits binding and resistance.This observation is unrelated to the reported event and does not cause or contribute to the ua 17 error message observed during archive data review.Upon customer approval, the platform will be serviced and will be further tested to full specification.Historical records were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number 12904.

• 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: 6790397
• MDR Text Key: 82867482
• Report Number: 3010617000-2017-00614
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2009
• 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: 70 YR