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

Catalog Number 397002-001

Device Problem Disconnection (1171)

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

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion 2 driver was not in use by a patient.The customer reported that the companion 2 driver that was in the hospital's equipment storage room was disconnected from the companion docking station.The docking stations, companion hospital cart and companion caddy, are designed to facilitate mobility of stable patients while in the hospital.The docking stations can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, the companion 2 driver has redundant, alternate power sources of external batteries and an internal, emergency battery.Syncardia initiated a capa (corrective and preventive action) to address the companion driver hospital cart / caddy power cord issue.The root cause investigation is ongoing.Potential corrective actions will be evaluated when the root cause investigation has been completed.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: HOSPITAL CART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5579616
• MDR Text Key: 43357858
• Report Number: 3003761017-2016-00148
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• 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: 03/29/2016
• 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