MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® NIMH BATTERY

Model Number 8700-0702-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 12/25/2013

Event Type  malfunction  

Event Description

Customer received a call on (b)(6) 2013 regarding a (b)(6) unresponsive male patient.Patient was found lying on his back in the front yard of his rental property.He was down for an unknown length of time.Bystander cpr was performed by his son for about 7-10 minutes.Customer deployed the autopulse platform upon arrival on scene with no issues.The platform powered on but did not perform any compressions.No error messages were observed.Customer replaced the autopulse nimh battery with their spare nimh battery right away but this did not resolve the issue.Customer reverted to manual cpr for the duration of transport to the hospital, which was about 12-20 minutes.The hospital was 11.1 miles from the scene of incident.At the hospital, manual cpr was continued for an unknown length until the physician pronounced the patient.Return of spontaneous circulation (rosc) was never achieved.Patient died on the same day due to a heart attack.Customer does not attribute the patient's death to the use of the autopulse.He stated that the patient was already "gone" before they got there.Patient was diabetic but had no history of heart issues.

Manufacturer Narrative

Customer stated that because they are a small unit, they cannot perform daily swaps of the batteries so the batteries are swapped out every 2 weeks.They are on a 4 battery rotation.The batteries charged up ok when they were initially received.Charger and battery indicated that the batteries were ready for use with the green led illuminated on both.Additional information provided on (b)(6) 2014 revealed that the last time that the batteries were charged was on (b)(6) 2013 so the batteries were "dead" when the customer used them on (b)(6) 2013.Zoll 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.Please see the following related mfr.Reports: #3003793491-2014-00027 for autopulse resuscitation system model 100 with sn: (b)(4); #3003793491-2014-00029 for autopulse nimh battery #2 with sn: unknown.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH 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: 3584383
• MDR Text Key: 4139538
• Report Number: 3003793491-2014-00028
• 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
• Report Date: 12/26/2013

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: 8700-0702-01
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR