MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review and functional testing.Load cell was found defective and a replacement was required.Visual inspection was performed and found damaged top and front covers, the backlight of lcd is not functional and encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported issue.To remedy the backlight of lcd issue, the lcd cable was reconnected to the processor board.Upon customer approval, the damaged parts will be replaced and sticky clutch plate will be deburred.The platform will be further tested to full specification.The autopulse is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or user mishandling.During functional testing, user advisory (ua) 07 error message displayed upon powered on the device, thus confirming the reported complaint.Review of the archive data indicated error message user advisory (ua) 07 on the customer reported event date.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with serial number (b)(4).Ccr (b)(4), reported on feb 22, 2016.Defective load cell was replaced to remedy the issue.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 the autopulse platform (sn (b)(4)) was used in a cardiac arrest patient, it displayed error message of user advisory (ua) 07 upon pressing on the start button.The use of the autopulse platform was discontinued and manual cpr was performed for the duration of the transport time to the hospital.A return of spontaneous circulation (rosc) was not achieved and the patient was pronounced in the emergency room.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 (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

During the call, the autopulse platform (sn (b)(4)) was used on a (b)(6) years old male patient (estimated weigh at (b)(6)) in cardiac arrest.The autopulse platform exhibited user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message upon pressing on the start button.The use of the autopulse platform was discontinued and manual cpr was performed for the duration of the transport time to the hospital.A return of spontaneous circulation (rosc) was not achieved and the patient was pronounced in the emergency room.Cause of the death was due to the cardiac arrest/dialysis.According to the reporter, the patient outcome was not attributed to the device.In addition, autopulse platform was checked after the call with the new lifeband; however, the error message persisted.

• 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: 8241175
• MDR Text Key: 132940685
• Report Number: 3010617000-2019-00029
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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: 68 YR
• Patient Weight: 113