MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY; EXTERNAL POWER SUPPLY

Catalog Number 295400-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom hospital power supply was not in patient use.The freedom hospital power supply has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom hospital power supply was not in patient use.The freedom hospital power supply is a power supply unit which has an integrated, molded wall input power cord.The hospital ac power supply connects the power adaptor to a wall power outlet.The customer, a syncardia certified hospital, reported that the freedom driver power supply had a cracked connector housing and still worked but would not fasten.

Manufacturer Narrative

Visual inspection of the power supply confirmed the customer-reported broken connector housing.The freedom hospital ac power supply did not pass the functional evaluation due to the broken housing.The root cause of the damage could not be conclusively determined; however, the nature of the break indicated that it was most likely due to rough handling.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.Ce 4916 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8937062
• MDR Text Key: 159642007
• Report Number: 3003761017-2019-00250
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1