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

Model Number 8700-0752-01

Device Problem Loss of Power (1475)

Patient Problems Cardiac Arrest (1762); Death (1802); Vomiting (2144)

Event Date 08/10/2014

Event Type  malfunction  

Event Description

It was reported that an initial call came into (b)(6) fire department on (b)(6) 2014 for an unresponsive (b)(6) year old male patient, weighing approximately (b)(6).The cardiac arrest occurred at the patient's residence and it was unwitnessed.Patient had no complaints prior to the arrest.It is unknown how long the patient was down prior to responding agency's arrival.Bystander cpr was not performed.Manual cpr was performed for a few minutes by (b)(6) police department.(b)(6) fire department took over and continued manual cpr, however, exact duration is unknown.The autopulse platform was deployed without any issues.The platform performed compressions for a total of 12 minutes and then stopped and powered off.No error messages were observed.The autopulse li-ion battery was replaced and compressions were restarted without any issues.Manual cpr was performed while the battery was being exchanged.Direct video laryngoscopy was performed as there were some difficulties intubating due to the presence of blood and vomit in the patient's airways.Four rounds of epinephrine were also administered.The autopulse platform performed compressions for another 3-4 minutes before the patient was pronounced dead by the (b)(6) fire department.There were no issues with the platform after the crew replaced the battery.Patient never achieved rosc (return of spontaneous circulation).The cause of death is unknown.However, the customer indicated that the patient had a history of copd (chronic obstructive pulmonary disease) and stroke.Customer does not attribute the patient's death to the use of the autopulse.It is unknown if an autopsy was performed.No further information was provided.

Manufacturer Narrative

Please see the following related mfr.Report #: 3010617000-2014-00454 autopulse resuscitation system model 100 with sn: (b)(4).Zoll circulation 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.

Manufacturer Narrative

Visual inspection of the returned li-ion battery was performed and found no physical damage.The archive for the li-ion battery was reviewed and found no failures or anomalies.Li-ion battery s/n (b)(4) underwent and passed all testing at zoll.Per review of the autopulse archive, it was determined that this battery is not being properly maintained.If proper battery maintenance is not performed (charged/test cycled) as instructed per the ifu, the batteries life span will be adversely effected.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4060272
• MDR Text Key: 4902053
• Report Number: 3010617000-2014-00455
• 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,Followup
• Report Date: 08/19/2014

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: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2013
• 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
• Treatment: MANUAL CPR
• Patient Age: 81 YR
• Patient Weight: 82