MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM A/C POWER SUPPLY

Catalog Number 295050-001

Device Problems Crack (1135); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

The freedom a/c power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that a patient's a/c power supply was cracked.The patient was provided with a replacement a/c power supply.There was no reported 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.The freedom driver has a redundant power source of onboard batteries.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

• Brand Name: SYNCARDIA FREEDOM A/C POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq., vp ; 1992 e. silverlake road; ce 2308; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4205674
• MDR Text Key: 15364326
• Report Number: 3003761017-2014-00155
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR