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

Catalog Number 293001-001

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

The companion external battery will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion external battery discharge time was outside the testing acceptance criteria.

Manufacturer Narrative

During investigation testing, the battery passed all functional procedures.The battery performed as intended with no evidence of a device malfunction.The reason for the battery initially failing the evaluation procedure was most likely due to the tolerance window of the voltage that the battery allowed to be charged.The companion external battery evaluation procedure has subsequently been revised and was released in may 2021 to allow batteries to charge and discharge at a more consistent rate that better matches field conditions in the driver.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) 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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11378878
• MDR Text Key: 233555908
• Report Number: 3003761017-2021-00031
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

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: Other
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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