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

Catalog Number 397003-001

Device Problem Failure to Charge (1085)

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

Event Date 10/08/2014

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.This syncardia companion hospital cart was not in use by a patient.The customer reported that a companion 2 driver that was docked into the hospital cart was not charging the external batteries.The customer also reported that when he turned the companion 2 driver on it would charge, but when the device was turned off, it stopped charging.The customer moved the companion 2 driver to a different hospital cart and it began to charge the batteries.

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the hospital cart was not in patient use.In addition, the reported issue would not prevent a companion 2 driver from performing its life sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARIDA 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: 4212560
• MDR Text Key: 5152313
• Report Number: 3003761017-2014-00224
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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