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

Model Number 8700-0752

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse battery for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

It was reported that the customer is experiencing low runtimes on battery with sn : (b)(4).Customer reported that when fully charged they get about 15-20 minutes of compressions on the autopulse platform.The battery was last charged on (b)(6) 2016 at 6:00 am and showed an orange light.Customer reported that the issue happened during shift check and during patients use.Customer used a different battery after the incident occurred during patients use and no injury or impact reported on the patient.

Manufacturer Narrative

The primary complaint was not confirmed.The battery passed functional testing and no errors were observed in the archive data.The reported battery was found to function as intended.The customer's issue could not be replicated nor confirmed, as a result, the root cause of the reported issue could not be determined.The battery was manufactured in october 2012, and has exceeded its three years cycle of service.

• 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: 6172280
• MDR Text Key: 62378805
• Report Number: 3010617000-2016-00880
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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