MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION HOSPITAL CART

Catalog Number 397002-001

Device Problems Use of Device Problem (1670); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

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.The hospital cart can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.On (b)(6) 2014, the customer reported to syncardia that the companion hospital cart was found to be unplugged from external wall power in the patient's room, and the companion 2 driver that was docked into the hospital cart was being powered by the internal emergency battery.There was no reported impact on the patient.Syncardia has requested additional information from the customer and an investigation will be conducted.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carol marcot, vp, esq. ; 5205451234
• MDR Report Key: 3812614
• MDR Text Key: 16015126
• Report Number: 3003761017-2014-00056
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• 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: 03/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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