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

Catalog Number 295050-001

Device Problems Break (1069); Physical Property Issue (3008); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because patients are provide multiple ac power supplies and the (b)(6) driver has a redundant power source of onboard batteries.The (b)(6) ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Event Description

The (b)(6) ac power supply is a component that enables the (b)(6) driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the patient's (b)(6) ac power supply was damaged.There was no reported adverse patient impact.

Manufacturer Narrative

The freedom ac power supply was returned to syncardia for evaluation.Visual inspection revealed damage to the power brick, cord and connector.The ac power supply appeared to have sustained a drop or other rough handling resulting in a broken strain relief and damaged housing.Despite the physical damage, the ac power supply passed all electric functional testing and continued to provide life-sustaining power to the 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.

Event Description

The freedom 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 the patient's freedom ac power supply was damaged.There was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM AC POWER SUPPLY
• Type of Device: FREEDOM AC POWER SUPPLY
• 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: 6714531
• MDR Text Key: 80258776
• Report Number: 3003761017-2017-00123
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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
• Patient Age: 24 YR