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

Catalog Number 295600-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom home ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The freedom home ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom home ac power supply had connection difficulties as it did not attach to the freedom driver properly.

Manufacturer Narrative

Visual inspection of the freedom home ac power supply revealed a cracked hypertronics connector outer housing.This broken connector outer housing caused the connector to not attach properly and, therefore, caused the connector difficulties reported by the customer.The root cause of this damage could not be determined; but given the nature of the crack, it mostly likely was 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.Ce 5295 follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOME AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• MDR Report Key: 10096954
• MDR Text Key: 196585144
• Report Number: 3003761017-2020-00139
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1