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

Catalog Number 397002-001

Device Problems Failure to Power Up (1476); Battery Problem (2885)

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

Event Date 08/05/2015

Event Type  malfunction  

Event Description

The companion 2 driver was not in use by a patient.The customer reported that the companion 2 driver does not start up properly.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver 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 will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

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 did not start up properly.Companion 2 driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the interior components revealed no anomalies.The driver was placed on an esd workbench and disassembled for visual inspection of the interior components.Visual inspection of the interior components revealed no anomalies.The patient file was copied and revealed no anomalies.During failure investigation testing, the customer reported issue of the driver not booting up to the proper user interface was duplicated with the root cause being the 3v (b)(4) battery.The driver was not in patient use when the customer reported issue occurred.Although the driver did not boot up properly, risk to the patient would have been low because the initial evaluation of the driver demonstrated that the driver continued to perform its life-sustaining functions.Additionally, centers are equipped with backup drivers.The battery was replaced and the driver passed all final performance testing.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.

• 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: 5001347
• MDR Text Key: 24678003
• Report Number: 3003761017-2015-00254
• 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
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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