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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Cardiac Arrest (1762)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

An initial call came in on (b)(6) 2015 for an (b)(6) male patient weighing (b)(6).Patient's height was approximately (b)(6).It is unknown what the patient's medical history was and what medications the patient was taking.The initial call was for a cardiac arrest.(b)(6) fire department and (b)(6) ems staff were on scene.The cardiac arrest occurred at (b)(6) nursing home.The arrest was witnessed by the nursing staff at 15:49 prior to calling 9-1-1.Bystander cpr was performed by the nursing staff, (b)(6) ems and then by (b)(6) fire (exact length of times were not provided).The fire department-ems crew deployed the autopulse platform.However, the platform would not engage and displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message.No compressions were provided by the platform.Ems did not attempt to troubleshoot and immediately removed the patient from the autopulse platform.Use of the platform was discontinued and manual cpr was continued (exact length of time was not provided).The patient was administered epinephrine.Return of spontaneous circulation (rosc) was never achieved.The patient was pronounced on scene in his room by the nursing home physician, at 16:15.It is unknown if an autopsy was performed.The cause of the cardiac arrest and death are unknown.Customer indicated that the patient's death was not related to use of the autopulse.No further details were provided.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESOR
• 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: 5085943
• MDR Text Key: 26111369
• Report Number: 3010617000-2015-00514
• 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: health professional
• Reporter Occupation: Health Professional
• Report Date: 08/25/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• 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: 87 YR
• Patient Weight: 64