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

Catalog Number 295050-001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

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.A syncardia customer service specialist reported that the plug on a patient's freedom a/c power supply was damaged.The patient was provided with a replacement a/c power supply.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.Although the lights on the freedom a/c power supply blinked, the freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries.

Manufacturer Narrative

An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

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.A syncardia clinical support specialist reported that the plug on a patient's freedom ac power supply at (b)(6), was damaged.The patient was provided with a replacement ac power supply.There was no reported adverse patient impact.Freedom ac power supply s/n (b)(4) was returned to syncardia for evaluation.The ac power supply was tested and failed multiple operations that prohibited connection to the power adaptor for powering the freedom driver.The ac power supply failed mechanical testing for a damaged connector, a missing rubber foot, and a broken ac cord strain relief.Freedom ac power supply s/n (b)(4) will be 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: 4279940
• MDR Text Key: 5008121
• Report Number: 3003761017-2014-00260
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR