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

Model Number MODEL 100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that (b)(6) ambulance responded to a difficulty breathing call.The patient was a (b)(6) year old male.Weight of the patient is unknown.The incident occurred while the patient was in bed and was found unconscious and in agonal arrest.No bystander cpr was being performed.The patient had a history of copd.Other medical histories, medication and allergies were unknown to those on scene.When the ambulance crew arrived on scene, medics removed the patient from the bed and placed him on the floor.Manual cpr was performed for approximately 5 minutes before the autopulse was deployed.The crew checked the patient's initial rhythm and confirmed that the patient had no pulse and was in asystole.The autopulse was deployed without any issues and performed compressions for approximately 15-20 minutes and then the device stopped.The battery was checked and there were no issues.The crew attempted to restart the platform by checking the patient's position and ensuring that the lifeband was not twisted.The platform was able to restart and perform another few compressions.However, it stopped again.An error message was observed on the lcd display.However, the customer could not recall what message was displayed.Use of the autopulse was discontinued and the crew reverted to manual cpr (exact length of time was not provided).Return of spontaneous circulation (rosc) was never achieved and the patient was pronounced on scene by the medical controller.The customer stated that they run a protocol before calling it into the medical controller.The cause of the cardiac arrest is unknown, however the customer does not believe that the autopulse caused or contributed to the patient's death.No further information was provided.

Manufacturer Narrative

It was also reported that the screw that holds the lifeband in place on the bottom of the platform became loose.Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

• 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: 4822702
• MDR Text Key: 5844549
• Report Number: 3010617000-2015-00306
• 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
• Report Date: 05/11/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 44 YR