MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART; CIRCULATORY ASSIST DEVICE

Catalog Number 397003-001

Device Problem Intermittent Continuity (1121)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery phase.The customer reported that the companion hospital cart display screen was working intermittently.The companion 2 driver supporting the pt was switched to another hospital cart.There was no pt impact.This alleged failure mode a low risk to the pt, because the reported issue had no effect on the ability of the companion 2 driver to perform its life-sustaining functions.In addition, the companion 2 driver has its own display screen.An investigation will be conducted by syncardia and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• 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: 4080930
• MDR Text Key: 4825663
• Report Number: 3003761017-2014-00094
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397003-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2009
• 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: 42 YR