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

Model Number 8700-0752-01

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery was returned to the manufacturer and evaluated.During evaluation of the returned battery, the reported complaint was confirmed.Evaluation and testing indicated that the cause of the customer reported issue was physical damage sustained during use.

Event Description

Complainant alleged that the lock lever on the autopulse® li-ion battery has broken off and it cannot be used.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

• 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: 4458108
• MDR Text Key: 13017490
• Report Number: 3010617000-2015-00065
• 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: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• 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: 01/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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