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

Catalog Number 295600-001

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient reported that the freedom ac power supply wall cord stopped working.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries, and patients are provided with backup ac power supplies.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient reported that the freedom home ac power supply wall cord stopped working.There was no reported adverse patient impact.The freedom home ac power supply was returned to syncardia for evaluation.The home ac power supply failed functional testing because the unit was not able to provide output voltage, duplicating the customer experience.The exact cause for this failure is unknown.This failure mode poses a low risk to the patient because the freedom driver has a redundant power source of onboard batteries, and patients are provided with backup ac power supplies.The freedom home ac power supply was taken out of service.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 AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• 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: 5627465
• MDR Text Key: 45302792
• Report Number: 3003761017-2016-00174
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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
• Patient Age: 39 YR