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

Catalog Number 295070-001

Device Problems Break (1069); Device Operational Issue (2914)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The freedom power adaptor was not supporting a patient.The customer reported that the freedom power adaptor has a broken mounting rail.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom power adaptor was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.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) follow-up.

Event Description

The freedom power adaptor was not supporting a patient.The customer reported that the freedom power adaptor has a broken mounting rail.The freedom power adaptor was returned to syncardia for evaluation.Visual inspection of the freedom power adaptor revealed damage to the mounting rail and indicator light lens.The freedom power adaptor was functionally tested and passed all functional testing.Because of the damage to the mounting rail and indicator light lens, the freedom power adaptor was taken out of service.This failure mode poses a low risk to a patient because the issue was observed when the freedom power adaptor was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.

• 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: 5498865
• MDR Text Key: 40538739
• Report Number: 3003761017-2016-00084
• 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
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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: Health Professional
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2015
• 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