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

Model Number 397002-001

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

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.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the touch screen on the companion 2 driver display does not respond.

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Incoming testing confirmed that the driver touch screen functioned as intended.The hospital cart touch screen calibration, however, was found to be offset.This offset was corrected by selecting "cart calibration" on the driver screen and completing the calibration on the cart screen.After calibration, both screens functioned as intended.During each calibration process, the driver and hospital cart screens, respectively, responded to the finger touching each circle.The calibration data for both screens is stored on the driver and will remain until the calibration procedure is performed again.It is possible that at some point out in the field, the hospital cart calibration was inadvertently performed on the driver touch screen.In this situation, the driver touch screen would still have full functionality, but the hospital cart touch screen calibration would be affected when the driver is placed into a hospital cart.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the touch screen on the companion 2 driver display does not respond.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6672119
• MDR Text Key: 78668455
• Report Number: 3003761017-2017-00106
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2013
• 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