MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® NIHM BATTERY; NI-HM BATTERY

Model Number 8700-0752

Device Problems Positioning Failure (1158); Device Stops Intermittently (1599)

Patient Problem Not Applicable (3189)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse battery 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.Not returning to zoll.

Event Description

A call was dispatched for an (b)(6) year old female that was not breathing.Upon arrival, the firefighters, paramedic and engineer were met outside by the relative who stated the patient was not breathing.The patient was found lying on the floor with a bystander manual cpr in progress (exact length of time not provided).The patient had been moved from the bed to the floor by the bystanders.The patient was not breathing, unconscious and appeared to be in cardiac arrest.The crew obtained information from patient's boyfriend who stated that the patient was last see approximately 2 hours ago and was vomiting the night prior and had a history of diabetes.The absence of pulse and breathing were verified by the firefighter.The crew moved the patient from bedroom floor to an area in the basement with more room for better patient access.Manual cpr was initiated and iv access was obtained in the right ante cupital.An oral airway adjunct was also placed by one of the crew.The patient was placed on the autopulse without any issues.However, the platform displayed "realign patient" message.After the patient was realigned, the platform was powered on.The lifeband retracted and the platform performed a partial compression and completely powered off.The use of autopulse was aborted and the crew reverted to manual compression.The crew gave 4 rounds of epinephrine with directions of paramedics present on scene.Manual compression and ventilations were continued until the paramedic instructed to stop.Rosc was never achieved.Autopsy was performed, however the cause of death has not been determined.The ems coordinator stated that they determined that the nimh batteries, used during the call, were the cause of the autopulse platform stopping compressions.Per the ems coordinator, the death was not attributed to the autopulse platform.

• Brand Name: AUTOPULSE® NIHM BATTERY
• Type of Device: NI-HM BATTERY
• 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: 5344126
• MDR Text Key: 35069147
• Report Number: 3010617000-2016-00011
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111002042
• UDI-Public: 00849111002042
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: No
• 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