MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM BATTERY CHARGER

Catalog Number 295054-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The freedom battery charger has been returned to syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported a concern about the patient's freedom battery charger when plugged into the wall with a hospital ac power supply because the green light on the power supply was blinking.The light on the power supply was a steady green light (no blinking) with the hospital's backup freedom battery charger.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue could not be reproduced or verified during this investigation.Functional inspection and testing found all four wells of the charger to be providing charging support and the power supply led to be emitting a solid green light as intended.The ac power supply used by the customer at the time of the reported event was not returned and therefore could not be used during the investigation.The freedom battery charger performed as intended with no evidence of a device malfunction.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.Ce 5112 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM BATTERY CHARGER
• Type of Device: BATTERY CHARGER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az AZ 85713
• MDR Report Key: 9548606
• MDR Text Key: 174684662
• Report Number: 3003761017-2020-00003
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 05/12/2020

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: Health Professional
• Device Catalogue Number: 295054-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR