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

Catalog Number 397003-001

Device Problems Battery Problem (2885); Power Problem (3010)

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

Event Date 02/21/2014

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 customer reported the companion 2 driver had 45 minutes of battery life left, even though the companion 2 driver was docked into the companion hospital cart which was plugged into a/c wall power.He switched the hospital cart power cord to a different wall outlet, and this did not remedy the situation.The plug was then wiggled in the hospital cart and the companion 2 driver went back onto wall power with the batteries charging.The customer then taped the cord to the companion hospital cart to prevent the plug from coming dislodged.The customer also reported that there was no pt impact and the pt was still being supported by the companion 2 driver and companion hospital cart.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3737890
• MDR Text Key: 4278319
• Report Number: 3003761017-2014-00039
• 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: 03/10/2014

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: 397003-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1