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

Catalog Number 293001-001

Device Problem Battery Problem (2885)

Patient Problem No Information (3190)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

These companion external batteries were not in use by a pt.The customer reported that the companion external batteries that were in stock at the implant center were "both dead." the customer also reported that the companion external batteries had been installed in a companion 2 driver at the implant center but the driver had not been plugged into external wall power.The customer also reported that the implant center then attempted to charge the batteries for about a week but the batteries did not charge.

Manufacturer Narrative

This alleged failure mode poses a low risk to a pt because the issue was observed when the companion external batteries were not in pt 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.The companion external batteries will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.Ref report # 3003761017-2014-00083.

• Brand Name: SYNCARDIA COMPANION EXTERNAL BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3821350
• MDR Text Key: 4390507
• Report Number: 3003761017-2014-00060
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2014

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: 04/15/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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