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

Catalog Number 295050-001

Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom ac power supply was not in patient use.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the ac power supply has a loose connection to the power adaptor, resulting in intermittent external power connection.This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom ac power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

This freedom ac power supply was not in patient use.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the ac power supply has a loose connection to the power adaptor, resulting in intermittent external power connection.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection revealed a broken positive wire inside the connector.The freedom ac power supply failed functional testing due to a broken positive wire in the connector inhibiting power from reaching the driver.The root cause for the customer-reported loose connection is the broken positive wire in the power supply connector.The freedom ac power supply was taken out of service.This failure mode poses a low risk to a patient because this issue was observed when the freedom ac power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.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.

• Brand Name: SYNCARDIA FREEDOM AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5626173
• MDR Text Key: 44911422
• Report Number: 3003761017-2016-00183
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2012
• 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