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

Catalog Number 295050-001

Device Problems Difficult to Insert (1316); Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2016

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 green connector of the freedom ac power supply was difficult to insert and was not recognized by the freedom power adaptor.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) initial (duplicate of (b)(4)).This was submitted in error, as this is a duplicate report.The report has already been reported under mfr report # 3003761017-2015-00436.The investigation is ongoing and the results of the investigation will be provided in a follow-up mdr, under mfr report # 3003761017-2015-00436.

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 green connector of the freedom ac power supply was difficult to insert and was not recognized by the freedom power adaptor.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.This was submitted in error, as this is a duplicate report.The report has already been reported under mfr report # 3003761017-2015-00436.The investigation is ongoing and the results of the investigation will be provided in a follow-up mdr, under mfr report # 3003761017-2015-00436.Syncardia 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: 5396322
• MDR Text Key: 37343972
• Report Number: 3003761017-2016-00034
• 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
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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