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

Model Number 8700-702

Device Problems Thermal Decomposition of Device (1071); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Complainant alleged that when the user took the autopulse nimh battery from the charger, the battery touched the snap fastener of the physician's smock which resulted in a burn in both the smock and the battery connector.The physician felt a small shock but did not lose consciousness.This is the second time this incident occurred and is addressed under this mfr report.No further information was provided.

Manufacturer Narrative

Please see the following related mfr report: 3003793491-2014-00328 to address the first incident.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

Nimh battery (s/n (b)(4)) was returned to the manufacturer for investigation.Visual inspection of the returned battery found one of the guiding pins and battery pins to be damaged.Because of the noted damage, the battery was unable to be tested due to the possibility of shock/burn/short.The electrical connector's extension beyond the battery's face was checked relative to the protective alignment pins and visual inspection of the returned battery found one of the guiding pins and one of the battery pins to be damaged.It is not known whether the noted damage occurred before or after the reported incident.Accidental contact between terminals and metal object is considered a use error.Zoll ships batteries with a protective non-conducting cap on terminals.Also, the battery user guide (p/n 10762-001, section 5.2) includes a caution statement: "do not short the battery power leads.Electrical connection (short) between battery power leads on the connector permanently damages the battery and renders the battery inoperable".An investigation conducted using the batteries serial number, found that the battery was within its expected life span of 2-4 years, with a manufacture date of 8/2012.The expected service life of the autopulse battery is 100 charge cycles or 2 to 4 years depending on battery maintenance and usage patterns.As the test cycles were not logged on the battery, readings were unable to be obtained and it was unable to be determined if the battery was 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® 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: 3920356
• MDR Text Key: 4582349
• Report Number: 3003793491-2014-00326
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-702
• Device Catalogue Number: 8700-0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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