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

Model Number 397002-001

Device Problems Battery Problem (2885); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver exhibited an emergency battery error alarm.

Manufacturer Narrative

The emergency battery smbus data was reviewed and showed no permanent faults or diminished capacity that would indicate a malfunction of the emergency battery.The companion 2 driver was plugged in to a/c power for an extended period of time; over 48 hours.This extra charging time allowed the emergency battery to fully recover and subsequently the driver functioned as intended and the driver passed all steps in the companion 2 driver final assembly functional test procedure.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation 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: 10885851
• MDR Text Key: 222557053
• Report Number: 3003761017-2020-00235
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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: Other
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1