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

Catalog Number 295600-001

Device Problems Failure To Run On AC/DC (1001); Power Problem (3010)

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

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

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 "faulty".The patient was provided a back-up freedom ac power supply, and there was no reported adverse patient impact.

Manufacturer Narrative

The freedom hospital ac power supply was returned to syncardia for evaluation.Visual inspection of the external components revealed cracked outer housing on the connector and damage to one of the strain reliefs to the transformer.Visual inspection of the internal components revealed a copper coil dislodged from its soldered connection on the printed circuit board (pcb).Functional testing confirmed the customer-reported issue of a faulty power supply as it did not provide any output.The root cause of the customer-reported issue was determined to be a malfunction of the pcb due to the disconnected copper coil.The power supply showed evidence of an impact shock or rough handling that most likely caused the copper coil to become disconnected from the board.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 "faulty".The patient was provided a back-up freedom ac power supply, and there was no reported adverse patient impact.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• Type of Device: FREEDOM HOSPITAL 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: 6677646
• MDR Text Key: 78985380
• Report Number: 3003761017-2017-00114
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• 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