MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM POWER ADAPTOR; AC POWER ADAPTOR

Catalog Number 295070-001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because it would not prevent the driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom power adaptor has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the freedom power adaptor led light flashed while supporting a patient.The customer also reported that the power adaptor was exchanged and there was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue of the power adaptor led blinking was confirmed and reproduced.Investigational testing determined that after depleted onboard batteries have been recharged by the system and then the system is left to run, the voltage on r25 can exceed the 5.6vdc thus powering off the led (5.6vdc is the led threshold).This was previously investigated and determined to be caused by the degradation of the c31 capacitor.The results of the functional inspection found that while the flashing of the led is not cosmetically ideal or intended, it does not hinder the power supply from interfacing with the driver and providing proper power to the driver, as the power adaptor passed all final test acceptance criteria.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7862171
• MDR Text Key: 119807854
• Report Number: 3003761017-2018-00459
• 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: 10/16/2018

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: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR