MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397003-001

Device Problems Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The customer reported that the companion 2 driver, which was docked in a companion hospital cart, displayed a timer on its touch screen, indicating that the companion 2 driver was using external battery power, even though the hospital cart was plugged into external wall power.The customer also reported that the power cord was inspected and was not fully seated in the companion hospital cart.The customer also reported that when the power cord was reseated, the timer was no longer displayed on the driver touch screen and the external batteries were observed to be charging.Syncardia initiated a capa (corrective or preventive action) to address the issue of the power cord inadvertently disconnecting or loosening in the companion hospital cart and driver caddy, and the corrective action is in process.This failure mode poses a low risk to the patient because it would not prevent the companion 2 driver from performing its life-sustaining functions.In addition, the companion 2 driver has redundant, alternate power sources of external batteries and an internal, emergency battery.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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: 5949173
• MDR Text Key: 55058705
• Report Number: 3003761017-2016-00319
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• 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: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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
• Patient Age: 27 YR