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

Model Number 8700-0752

Device Problem Device Inoperable (1663)

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

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported that during a call, the autopulse platform stopped operating multiple times and had to be restarted.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse battery in complaint was returned to zoll on 03/16/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Please see the following related mfr.Report #3010617000-2015-00169 for autopulse® resuscitation model 100 with sn: (b)(4).

Manufacturer Narrative

Please note that the initial report indicated that the device in complaint was returned on 03/16/2015.However, upon further inspection, it was determined that the customer returned the wrong battery.Additional follow-up information from the customer indicated that the battery (sn: (b)(4)) in complaint could not be located for return to the manufacturer.Therefore, a physical investigation will not be performed.A supplemental report will be submitted if the product is returned and 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: 4633585
• MDR Text Key: 5591618
• Report Number: 3010617000-2015-00170
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• 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