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

Model Number 8700-0752-01

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

Complainant alleged that an autopulse® li-ion battery (s/n (b)(4)) would not stay seated in the autopulse® platform.However, when placed into the charger, the battery was able to be seated.It appears that one of the tabs in front of the battery was damaged.There were no issues when another battery was placed into the autopulse® platform.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

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.

Manufacturer Narrative

The autopulse battery (s/n (b)(4)) was returned to the manufacturer and evaluated.The battery would not stay seated in a test autopulse platform.Visual inspection identified that one of the battery's right connector pins was damaged leading to the reported issue.Based on condition of the pin, the damage appears to have occurred during use and handling of the battery in the field.

• 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: 4211929
• MDR Text Key: 4986009
• Report Number: 3010617000-2014-00572
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• 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: 10/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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