MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

Catalog Number 293001-001

Device Problems Electrical /Electronic Property Problem (1198); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the companion 2 driver continued to perform its life-sustaining function.The companion external battery has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion external battery was not properly charging.The customer also reported no adverse patient impact.

Manufacturer Narrative

Visual inspection and system management (smbus) data review revealed no damage or abnormalities.The companion external battery passed all functional testing requirements including the required charge/discharge test.The battery performed as intended with no evidence of a device malfunction.Therefore, the root cause of the customer-reported inability to charge could not be determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4688 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8432843
• MDR Text Key: 139214579
• Report Number: 3003761017-2019-00049
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR