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

Catalog Number 295400-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the device was not in patient use.The freedom hospital ac 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 ac power supply was not in patient use.The freedom hospital ac 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 outer sleeve of the green connector of the freedom driver hospital ac power supply was loose and came off easily.

Manufacturer Narrative

Visual inspection of the power supply revealed a missing connector outer housing and a broken white hypertronics connector.The broken connector would cause the connector outer housing to not attach properly and cause the connector fixture to come loose confirming the customer-reported issue.The root cause of this damage could not be determined, but given the nature of the malfunction, it may be due to rough handling, or wear and tear of the product.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) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• Type of Device: EXTERNAL PWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az AZ 85713
• MDR Report Key: 9532655
• MDR Text Key: 174685090
• Report Number: 3003761017-2019-00372
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/10/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1