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

Catalog Number 397001-001

Device Problem Failure to Charge (1085)

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

Event Date 12/19/2014

Event Type  malfunction  

Event Description

This companion driver caddy was not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer reported that the companion driver caddy "does not seem to charge anymore".This alleged failure mode poses a low risk to the patient because the issue was observed when the companion driver caddy was not in use by a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external batteries and an internal, emergency battery.An investigation will be conducted by syncardia and the results will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA COMPANION DRIVER CADDY
• 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: 4380606
• MDR Text Key: 5114887
• Report Number: 3003761017-2014-00326
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397001-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2012
• 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