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

Catalog Number 295070-001

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom power adaptor is loose and would not lock into the freedom 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

(b)(4) fup 1.

Event Description

The customer reported that the freedom power adaptor was loose and would not lock into the freedom driver.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.The freedom power adaptor was returned to syncardia for evaluation.Visual inspection of the exterior revealed that the power adaptor did not have the retention clip on the mounting rail, but had mounting rail shims, which secure the power adaptor in place on the freedom driver during normal operation but do not "lock" the power adaptor in place.During the investigation, there was no difficulty in mating the power adaptor to a freedom driver.The connection was as expected for a power adaptor with mounting rail shims.The output connector of the power adaptor also mated properly with the input receptacle of a freedom driver and locked in place.The power adaptor was tested and passed all electrical and functional testing.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.

• 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: 5436256
• MDR Text Key: 38865775
• Report Number: 3003761017-2016-00055
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• 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: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 52 YR