MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-070X

Device Problems Device Alarm System (1012); Material Twisted/Bent (2981)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

An (b)(6) year old female patient weighing about (b)(6) kg experienced a cardiac arrest at her home.Patient had a history of dementia, cataract and glaucoma.The arrest was witnessed by her daughter.It is unknown if bystander cpr was performed.The ems crew arrived 15-20 minutes later.Manual cpr was initiated by the ems crew for about 30 minutes until they arrived at the hospital.The medical staff at the hospital deployed the autopulse platform when the patient was carried to the er.The physician/nurse indicated that the patient was correctly positioned on the platform with the yellow upper edge of the lifeband aligned with the patient's armpits and directly over the yellow line on the autopulse platform.The medical staff stated that the patient was wearing a thin undershirt, which did not interfere with the operation of the autopulse.The staff did not observe that the lifeband was twisted.They did pull the lifeband completely up prior to starting compressions.There were no messages on the platform's display.The platform performed about 2 minutes of compressions and then stopped.The physician observed that the lifeband was broken (cut) and discontinued use of the platform.They immediately reverted to manual cpr for another 20 minutes.Return of spontaneous circulation (rosc) was never achieved.The cause of patient's death was cardiopulmonary arrest (cpa).The physician (chief of er), verbally stated that this event did not contribute to the patient's death because the patient's original condition was cpa.No further information was reported.

Manufacturer Narrative

The autopulse lifeband in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll on (b)(4) 2015 for investigation.Investigation results as follows: the customer's reported event that the lifeband was broken (cut) was confirmed during visual inspection.It was observed that the lifeband belt was broken.Investigation of the lifeband indicated that the rough edges observed along the right side of the lifeband belt may have shifted to the right side and to an angle, causing the lifeband belt to get caught on the autopulse roller on the right hand side, during active operation.This would have caused the lifeband belt to cluster up, causing the length of the lifeband belt to shorten.Since the autopulse platform was in active operation, the pulling force of the lifeband belt material during use may have caused the propagation of stress concentration on the belt material leading to the breakage which occurred 0.54" below the chest compression assembly (cca) pin breakaway link and stitch line.There were no device deficiencies found during evaluation of the returned lifeband which could have caused or contributed to the patient's death.Per the initial information reported by the customer, the cause of the patient's death was cardiopulmonary arrest (cpa).Furthermore, the physician (chief of er), verbally stated that this event did not contribute to the patient's death because the patient's original condition was cpa.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• 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: 4764204
• MDR Text Key: 5779415
• Report Number: 3010617000-2015-00273
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-070X
• Device Catalogue Number: 8700-070X
• Device Lot Number: 52531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MANUAL CPR
• Patient Age: 89 YR
• Patient Weight: 40