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

Catalog Number 295400-001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) hospital ac power supply will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

(b)(6) hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that (b)(6) hospital ac power supply had a damaged connector.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue of an unscrewed and damaged connector housing of power supply.Despite this damage, the power supply was still able to connect and power a freedom driver.The root cause of this damage could not be determined, but given the nature of the damage, it may be due to rough handling, or wear and tear of the product.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA 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: 11150537
• MDR Text Key: 226331425
• Report Number: 3003761017-2021-00002
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR