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

Catalog Number 295070-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of multiple onboard batteries.The freedom power adaptor 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 customer, a syncardia certified hospital, reported that the freedom power adaptor had a broken retention clip while attached to the freedom driver that was supporting a patient.There was no reported adverse patient impact.The customer also reported that a backup freedom power adaptor was attached to the freedom driver.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue of a damaged retention clip.Despite the observed damage, the driver in "as received" condition passed all functional testing.It cannot be conclusively determined what caused the latching mechanism to become damaged, but it was most likely caused by excessive force being applied while trying to connect the power adaptor to a corresponding freedom driver.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 POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9176925
• MDR Text Key: 161987355
• Report Number: 3003761017-2019-00294
• 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: 11/25/2019

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: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR