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

Model Number 397002-001

Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce 5287 initial.

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that during the daily system check, the companion 2 driver did not recognize the wall power and did not recognize the two external batteries that were installed.The external batteries showed full charge from the fuel gauge and the driver was plugged into the ac outlet.

Manufacturer Narrative

The customer-reported issue of the driver having an error for not detecting external batteries or external power (wall power) was not able to be reproduced during investigation testing.This investigation found that the driver functioned as intended and passed all requirements, which includes tests to confirm that the driver display shows a plug icon (indicating connection to external main a/c power) and for the hospital cart and driver to both display a plug icon indicating connection to a/c power when the driver is docked to the hospital cart.Additionally, external batteries that have previously met performance requirements were used to test the ability of the driver to recognize and charge external batteries, which the driver was able to do.The external batteries used by the customer at the time of the reported event were not returned and therefore could not be evaluated as part of this investigation.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5287 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 10068012
• MDR Text Key: 202078337
• Report Number: 3003761017-2020-00134
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 05/28/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1