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

Catalog Number 295070-001

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom power adaptor had a "flickering green light." the customer also reported that the patient's wife heard a "battery beep" like the driver wasn't plugged in.The wife confirmed that the associated freedom power supply cord was plugged in appropriately to the wall outlet and power supply and that the power adaptor was appropriately connected to the power supply and driver.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.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.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom power adaptor will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The freedom power adaptor was returned to syncardia for evaluation.Visual inspection of the power adaptor revealed that the connector was damaged.The damage was most likely the result of an impact shock.The power adaptor was tested and despite the broken connector, it passed all functional testing.No blinking of the led was observed during 13.5 hours of continuous operation.Further evaluation of the power adaptor was conducted while connected to a freedom driver and ac wall power, and with onboard batteries of different charge levels.The power adaptor performed as intended, and the reported issues were not reproduced during the investigation.The freedom power adaptor was taken out of service because of the broken connector.The reported issue posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.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.(b)(4).

Event Description

The customer reported that the freedom power adaptor had a "flickering green light".The customer also reported that the patient's wife heard a "battery beep" like the driver wasn't plugged in.The wife confirmed that the associated freedom power supply cord was plugged in appropriately to the wall outlet and power supply and that the power adaptor was appropriately connected to the power supply and driver.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• 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: 5888713
• MDR Text Key: 53586766
• Report Number: 3003761017-2016-00270
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2010
• 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: 57 YR