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

Model Number 397002-001

Device Problem Failure to Power Up (1476)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue was observed with the companion 2 driver was not supporting a patient.The companion 2 driver has been returned to syncardia for evaluation.The results of the investigation 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 certified hospital, reported that the companion 2 driver could not turn on.

Manufacturer Narrative

During investigation testing, the driver performed as intended.Further power cycle testing (turning key on and off) indicated that the driver functioned as intended.The driver was then disassembled for an internal visual inspection.During this inspection, the wires of the key switch were found to have damage to their insulation, exposing bare wire.It is possible that this wire damage caused an intermittent short resulting in the inability to turn on, as reported by the customer.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• 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
• MDR Report Key: 7566352
• MDR Text Key: 110181850
• Report Number: 3003761017-2018-00218
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1