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

Catalog Number 295050-001

Device Problems Break (1069); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

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 the pt's freedom a/c power supply was damaged.The pt was provided with a replacement a/c power supply.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because it did not prevent the freedom driver from performing its life-sustaining functions.Although the freedom a/c power supply was damaged, the freedom driver continued to function as intended.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.

• Brand Name: SYNCARDIA FREEDOM A/C POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq., vp of reg a ; 1992 e. silverlake rd.; ce 2459; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4280013
• MDR Text Key: 5230127
• Report Number: 3003761017-2014-00263
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/05/2014

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: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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: 63 YR