MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

This companion 2 driver was not supporting a patient.The customer reported that the companion 2 driver displayed an "emergency battery low" alarm.The customer also reported that the driver was charged overnight, but after it booted up, the led next to the internal battery symbol flashed red.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, this alleged failure mode would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external batteries and wall power.An investigation will be conducted by syncardia and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• 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: 4080907
• MDR Text Key: 4746441
• Report Number: 3003761017-2014-00127
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2012
• 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