MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL BATTERY

Catalog Number 293001-001

Device Problems Device Inoperable (1663); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

This companion external battery was not in use by a patient.The customer reported that the implant center reported that this companion external battery "did not function." the customer also reported that when the implant center returned the battery to her office, she attempted to charge the battery over a two day period but the battery did not charge.The customer also reported that the companion external battery had been installed in a companion 2 driver at the implant center but that the driver had not been plugged into external wall power.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not in patient use.In addition, this alleged failure mode would not prevent a companion 2 driver from performing its life-sustaining functions, because the companion 2 driver has multiple power sources: external wall power, external batteries and an internal, emergency battery.

Manufacturer Narrative

The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION EXTERNAL BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esp, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3772581
• MDR Text Key: 15119839
• Report Number: 3003761017-2014-00041
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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