MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752

Device Problems Defibrillation/Stimulation Problem (1573); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Electrocution (1827)

Event Date 12/20/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, the ems received a call for a patient in cardiac arrest, post electrocution.An aed was applied on scene prior to ems arrival but no shocks were advised.Upon arrival, the ems crew placed the patient on the autopulse platform.The platform performed compressions for approximately 5 minutes using an autopulse li-ion battery with an unknown serial number (sn).When this initial battery depleted, the crew replaced the battery with another li-ion battery (sn (b)(4)).However, the platform did not perform any compressions with this second battery.The patient reportedly expired.No further information was provided.Manufacturer has requested additional information from the customer.However, no additional information has been obtained.

Manufacturer Narrative

Customer stated that after the call, the second battery (sn: (b)(4)) was brought back to the base and put into an autopulse multi-chemistry charger (mcc).The mcc status led initially illuminated yellow indicating that the battery was charging.However, the status led changed to red, which indicated that the battery had been disabled by the charger.In addition, when the battery's status check button was pressed, one red bar illuminated indicating that the battery should not be used.Customer is on a 3 battery rotation with batteries rotated once a week, even if not used.Customer also stated that batteries are changed after use.Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Please see the following related mfr.Reports: 1.#3010617000-2015-00155 for autopulse® resuscitation model 100 with sn: (b)(4).2.#3010617000-2015-00157 for autopulse® li-ion battery with sn: unknown.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION 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: 4625094
• MDR Text Key: 5762965
• Report Number: 3010617000-2015-00156
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• 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: 8700-0752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• 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