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

Catalog Number 295600-002

Device Problems Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom ac power supply was not in patient use.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 freedom ac power supply exhibited a green blinking light when connected to the battery charger.The customer also reported that the freedom batteries do not charge while connected to the freedom ac power supply.This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom ac power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.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

The brand name was revised to syncardia freedom home ac power supply eu.The part number was corrected from 295050-001 to 295600-002.(b)(4).

Event Description

This freedom home ac power supply was not in patient use.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 freedom home ac power supply exhibited a green blinking light when connected to the battery charger.The customer also reported that the freedom onboard batteries did not charge in the battery charger while connected to the freedom home ac power supply.The home ac power supply was returned to syncardia for evaluation.Visual inspection of the external components revealed no abnormalities.The home ac power supply was tested, and the reported issue of the unit not charging freedom onboard batteries was confirmed.The investigation determined that the root cause was reversed output polarity.The freedom home ac power supply was returned to the supplier for evaluation and repair.This failure mode posed a low risk to a patient because this issue was observed when the freedom home ac power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver system has been designed to include redundant power sources to ensure that continuous operation is maintained in the event that the external ac power supply fails to supply adequate power.The redundant power sources are multiple rechrgeable onboard batteries, a backup ac power supply and a car charger.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 HOME AC POWER SUPPLY EU
• 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: 5385121
• MDR Text Key: 37008462
• Report Number: 3003761017-2016-00021
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295600-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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