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

Catalog Number 397002-001

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

The driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported the companion 2 driver received an emergency battery error.

Manufacturer Narrative

Alarm history and patient data file review found review found new alarms recorded in the companion 2 driver's data file: on apr 24th there was an emergency battery error alarm that occurred multiple times.Visual inspection of external components revealed no abnormalities.Visual inspection of internal components revealed a damaged capacitor on the power management board though unrelated to this complaint.This finding handled per standard non-conformance procedures.Companion 2 driver passed all incoming functional testing.The battery was then subjected to a ten-minute battery discharge test.During this testing the battery performed as intended.Failure investigation for this complaint confirmed the reported issue via alarm history data review.The complaint was not replicated via functional/observational testing.The root cause of the customer reported emergency battery alarm could not be conclusively determined.Failure investigation identified no test failure, damage, or abnormalities that could have contributed to the customer reported alarm.Driver functioned as designed.Patient was switched to a back-up driver with no reported adverse impact.This issue weill be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.(if new or additional information is received in the future, syncardia will file a follow-up mdr.) (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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16872941
• MDR Text Key: 314909743
• Report Number: 3003761017-2023-00066
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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