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

Catalog Number 397002-001

Device Problem Failure to Power Up (1476)

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

Event Date 04/25/2014

Event Type  malfunction  

Event Description

The customer reported that the compressors on the companion 2 driver would turn on when the driver was connected to hospital wall air.The customer also reported that there was no patient impact and the patient was still being supported by the 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 syncarida.The results of the investigation will be provided in the 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: 3820601
• MDR Text Key: 4390470
• Report Number: 3003761017-2014-00065
• 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: 05/06/2014

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: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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: 44 YR