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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of autopulse platform (serial #(b)(4)) stopped compression and unknown user advisory (ua) error messages displayed during the entire process were not confirmed during functional testing but confirmed in the archive data.Ua17 was observed in the archive but could not be replicated during initial testing; therefore, the root cause was undetermined.No physical damage on the ap platform was observed during visual inspection.The autopulse platform is a reusable device and was manufactured in december 2007.The device has been operating for over 11 years and has exceeded its expected serviceable life of 5 years.During archive data review, multiple ua17 (max motor on time exceeded during active operation) occurred during the reported event date.Ua17 would cause the platform to stop performing compressions.Thus, confirming the reported complaint.The autopulse passed the initial functional test without any fault or error.The ap platform is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).Based on zoll 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.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.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 ((b)(6), 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

Customer reported that during a code 4 response for an unconscious patient and upon arriving at the scene, the emergency crew found the patient vital signs absent (vsa) in laneway supine position.Crew placed the patient on the autopulse platform (serial #(b)(4)) that was on a stretcher.A couple of times while running cardiac arrest protocol, the ap platform stopped compression.Crew realigned the patient properly and readjusted the lifeband securely on the patient chest.The crew would then restart the ap platform and continued with compressions.Once crew arrived at hospital, the ap platform would periodically stop and advised to realign patient who was still properly secured on the ap platform.Crew readjusted the lifeband and ap platform started doing compressions again.Shortly after, the crew noticed the ap platform was prompting that the battery has low voltage and stopped compression.The crew replaced the ap platform with a fully charged battery and after a short period of time, again the ap platform began prompting to realign the patient and continued with same issue.There were a few different user advisory (ua) error messages that came up during the entire process but crew could not recall exact ua.Crew assisted emergency room staff with manual cpr until patient was pronounced by the doctor.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8344160
• MDR Text Key: 136317399
• Report Number: 3010617000-2019-00148
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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