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

Catalog Number 397002-001

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The customer reported that the air indicator on the companion 2 driver display screen remained illuminated, even though the driver was connected to hospital wall air.The customer also reported that disconnecting and reconnecting the driver to hospital wall air did not resolve the issue, and the air indicator remained illuminated.The customer also reported that this issue had no impact on the patient, and the patient is still supported by this companion 2 driver.This alleged failure mode poses a low risk to the patient because it does not prevent the companion 2 driver from performing its life-sustaining functions.An investigation will be conducted by syncardia.The results of the investigation 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: 3809839
• MDR Text Key: 4524794
• Report Number: 3003761017-2014-00023
• 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: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• 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: 01/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2011
• 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
• Patient Age: 65 YR