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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that an initial call came into (b)(6) fire district department on (b)(6) 2014 for a middle aged patient that was experiencing chest pain.The cardiac arrest occurred on scene at the patient's place of residence, which was witnessed by the fire department.Manual cpr was performed for approximately 5 minutes by the responding agency.The patient was placed onto the autopulse platform on a flat surface and was not moved.The autopulse lifeband would not adjust or analyze the patient's chest size and then displayed a "check patient alignment" message.Responding agency attempted to turn the autopulse on and off, however the issue would not resolve.The platform was unable to perform any compressions.Patient was removed from the autopulse.Crew reverted to manual cpr for the remainder of the call which was approximately 20-30 minutes until the patient was transported to the hospital, where the patient was pronounced by the emergency room physician.Patient never achieved rosc (return of spontaneous circulation).The cause of death is unknown.Customer does not attribute the patient's death to use of the autopulse.Patient's weight and medical history were not provided.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(4) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Autopulse platform s/n (b)(4) was returned to zoll for evaluation.Visual inspection of the returned platform was performed and no physical damage to the platform was found.The returned platform was unable to undergo initial functional testing, as it exhibited ua7 (discrepancy between load 1 and load 2 too large) when it was powered on, which was unable to be cleared.A review of the archive was performed and found that the platform did not record any usage on the reported event date of (b)(6) 2014.The archive does however show that the platform began exhibiting an un-clearable ua7 on (b)(6) 2014.Load cell module 2 was replaced to remedy the reported complaint of the platform displaying a ua 7 code.Load cell characterization testing was performed to ensure that the load cells are functioning properly.The customer reported complaint of the platform displaying ua7 was confirmed through review of the archive, however, the archive indicated that the platform was not used on the reported event date of (b)(6) 2014.Load cell module 2 was replaced, and the platform underwent load cell characterization testing to confirm that both load cells are functioning properly.The platform did not cause or contribute to the patient outcome, as the platform was not deployed and was never in active operation.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4164540
• MDR Text Key: 4873103
• Report Number: 3010617000-2014-00509
• 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: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2003
• 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
• Treatment: MANUAL CPR