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

Model Number 397002-001

Device Problem Power Problem (3010)

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

Event Date 04/29/2020

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.(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported during a training class, 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

During investigation testing, 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 at the time of customer-reported issue were not returned and therefore could not be evaluated as part of this investigation.The customer-reported issue of the driver not detecting external batteries or external power (wall power) was not able to be reproduced and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.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 5279 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: 10062401
• MDR Text Key: 207349828
• Report Number: 3003761017-2020-00124
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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: 05/07/2020
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1