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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the platform powered off multiple times was confirmed during functional testing and based on the archive data review.The root cause was due to the defective power distribution board (pdb) as a result of wear and tear.The autopulse platform was manufactured in march 2014, and it is almost 6 years old, beyond its expected service life of 5 years.Further inspection of the returned platform revealed defective lcd backlight, thus confirming the customer reported complaint.The root cause was attributed to a defective processor board due to wear and tear.Visual inspection was performed and found no physical damage to the autopulse platform.A review of the autopulse platform archive was performed, and it showed multiple instances of the platform powering off occurred on the reported event date.Following the service and repair, the platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to the (b)(6) patient with good known test batteries until discharged and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with 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, when autopulse platform used on a (b)(6) female cardiac arrest patient, it powered off multiple times after performed 30 minutes' compressions.In addition, the lcd backlight was not working.As troubleshooting was not work, the manual cpr was performed for an unknown period of time.Rosc was not achieved and the patient was pronounced dead.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.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

Event Description

It was reported that during the patient call the autopulse platform performed compressions for 30 minutes and powered off multiple times.In addition, the lcd backlight was not working.As a troubleshooting step, the user replaced the batteries to power up the autopulse platform however, the platform did not power on.The manual cpr was performed for an unknown period of time.Rosc was not achieved and the patient was pronounced dead.Per customer, the patient's outcome is not related to the 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 9599238
• MDR Text Key: 179747319
• Report Number: 3010617000-2020-00030
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 01/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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: 51 YR