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

Catalog Number 295070-001

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom power adaptor exhibited a green blinking light instead od a solid green light when the freedom driver was connected to wall power.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.

Manufacturer Narrative

The freedom power adaptor will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).Please note that this is a corrected report.The freedom power adaptor serial number is (b)(4), not (b)(4).

Event Description

The customer reported that the freedom power adaptor exhibited a green blinking light instead of a solid green light when the freedom driver was connected to wall power.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.The freedom power adaptor s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the power adaptor did not reveal any abnormalities or anomalies.The power adaptor was functionally evaluated and passed all functional and mechanical tests.Further evaluation of the power adaptor, while connected to a freedom driver and ac wall power, was performed with onboard batteries of different charge levels.The power adaptor performed as intended, and there was no evidence of a device malfunction.The blinking of the freedom power adaptor green led as reported by the customer could not be duplicated.The reported issue posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and an external battery charger.Because freedom power adaptor s/n (b)(4) met the test acceptance criteria, it was returned to inventory.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.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4853606
• MDR Text Key: 5870273
• Report Number: 3003761017-2015-00185
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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