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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of drive shaft does not turn when the lifeband pin was installed on the autopulse platform (sn (b)(4)) was confirmed during visual inspection.Examination of the returned autopulse platform found that the drive shaft was exhibiting binding and resistance caused by a burr in the clutch plate.A clutch plate deburring was performed; however, the drive shaft still does not rotate freely.The autopulse platform was replaced with a new clutch plate to resolve the reported issue.The investigation findings revealed that the root cause of the reported complaint was due to a defective clutch plate.No physical damage on the autopulse platform was observed during visual inspection.During archive data review, no significant discrepancy identified.After part replacement, the platform was functionally tested and operated as intended with no further issue observed.The device passed all final specification.The autopulse platform is ready for clinical use.Historical records were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform 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.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 patient use, customer reported that the autopulse platform (serial # (b)(4)) functioned properly for about 15 to 20 minutes and then the shaft does not turn when the lifeband pin was installed.The issue occurred while treating a male patient after he had been delivered to the emergency department (ed).The male patient of unknown age in cardiac arrest who was described large - but well under the 300 lbs.Limit of the autopulse platform.After a short period of manual cpr, the ed applied their own autopulse platform to treat the patient.The patient never attained rosc and was pronounced.

• 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: 8363852
• MDR Text Key: 137422204
• Report Number: 3010617000-2019-00149
• 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: 02/22/2019

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: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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