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

Catalog Number 295070-001

Device Problems Connection Problem (2900); Physical Property Issue (3008); Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom power adaptor was not supporting a patient.The freedom power adaptor 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 power adaptor was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom power adaptor had a connection issue.

Manufacturer Narrative

The freedom power adaptor was returned to syncardia for evaluation.Visual inspection of the freedom power adaptor revealed some wear around the cover to the power pack connection and the power supply connection.Unknown sticker residue was found on the power adaptor, but it is highly unlikely that it or the observed cosmetic damage had any impact on the tightness of the connection between the driver and the adaptor due to the location of the wear and residue.The freedom power adaptor was attached to three freedom drivers in attempts to reproduce the customer-reported tightness.The reported tightness could not be reproduced during investigation testing, as the freedom power adaptor was able to be successfully connected to a freedom driver.The device performed as intended and did not exhibit any evidence of a device malfunction.This issue will continue to 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.

Event Description

The freedom power adaptor was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom power adaptor had a connection issue.

• 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
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6876077
• MDR Text Key: 87855004
• Report Number: 3003761017-2017-00177
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1