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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2015, (b)(6) received a call at 5:30 am for a mid (b)(6) male patient.The customer reported that during the call, after li-ion batteries were placed into the autopulse, the lcd display screen would not turn on.Use of the autopulse was discontinued and the customer reverted to manual cpr (exact length of time was not provided).The patient reportedly expired at the hospital.No further details were provided.Manufacturer has requested additional information from the customer.However, no additional information has been obtained.

Manufacturer Narrative

The customer also reported that during the morning shift check, the autopulse platform worked fine.Product in complaint was returned to zoll on 04/30/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation and was completed on 6/8/2015.Visual inspection was performed and no damages were observed.Prior to functional testing, the platform could not be powered on, thus confirming the reported complaint of the platform lcd display not functioning.Further testing indicated the cause to be a defective processor pca board.Following replacement of the processor pca board, functional testing was continued.Specifically, compression testing was performed using a large resuscitation test fixture for several hours with no user advisories or warning exhibited.Load cell characterization was also performed which confirmed that both load cell modules were functioning within specification.A brake gap inspection was also performed, which verified that the brake gap was within the specification of 0.008" ±0.001".Following replacement of the processor pca board, the autopulse platform performed as intended.Due to the condition in which the unit was received, the archive could not be downloaded and reviewed.Based on the investigation, the part identified for replacement was the processor pca board.In summary, the reported complaint of the platform lcd not functioning was confirmed during functional evaluation and is attributed to a defective processor pca board.There is no indication from the device evaluation that the autopulse platform caused or contributed to the reported patient outcome.Following service, including replacement of the processor pca board, the platform passed all functional test criteria.

Event Description

Additional information was received from the customer on 5/15/2015.A 9-1-1 call was placed on (b)(6) 2015 at 05:25 am regarding a (b)(6) male patient, with a previous history of cardiac bypass surgery.The patient had complained earlier of shortness of breath (sob).The patient was down for approximately 15 minutes before he was discovered in the supine position, by his wife in the entry way at his place of residence.(b)(4) fire were enroute at 05:27 am.The patient's wife was attempting to perform manual cpr, when (b)(4) fire arrived on scene at 05:31 am.The crew then initiated manual cpr at 05:33 am and opened the patient's airway.Ventilation of the patient using the bag-valve-mask (bvm) technique was also initiated.The crew then applied a cardiac monitor to assess the patient's heart activity and rhythm.The results showed that there was insufficient cardiac output and the patient was in a pea (pulseless electrical activity) state.At 05:35 am, the patient was placed onto the autopulse platform.When the device was powered on, the lcd screen was notably blank.Manual cpr was continued and the battery was exchanged, however the issue would not resolve.Use of the autopulse was discontinued and manual cpr was resumed on scene and during transport to the hospital.The patient was transported at 06:00 am, and arrived at the hospital at 06:06 am.Advanced life support (als) techniques were administered, including intubation, establishment of io (intraosseous infusion) and doses of epinephrine 1:10,000.Patient remained in a pea state upon arrival to the hospital.Resuscitation efforts were discontinued at the hospital by the ed staff.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead by the emergency department.It is unknown if an autopsy was performed.The cause of cardiac arrest and death are also unknown.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4767491
• MDR Text Key: 22161925
• Report Number: 3010617000-2015-00259
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2004
• 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: 79 YR