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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM AC POWER SUPPLY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295050-001
Device Problems Material Frayed (1262); 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 11/10/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom ac power supply cord had frayed, it did not prevent the freedom driver from performing its life-sustaining functions.In addition, 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.(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 power cord on the patient's freedom ac power supply had frayed.The patient was provided a back-up freedom ac power supply, and there was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed a broken strain relief, a missing connector o-ring and a damaged hypertronics connector.Foreign adhesive/tape was found on the strain relief, indicating an attempted repair of the power cord on the freedom ac power supply.Unauthorized rework on the freedom driver or any of the related accessories is prohibited.While the root cause of the issue could not be determined, based upon the damage observed and the evidence of attempted repair, it can be concluded the freedom ac power supply was subjected to improper use including rough handling and unauthorized rework the freedom ac power supply provided the proper output voltage and operated as intended for power delivery.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 power cord on the patient's freedom ac power supply had frayed.The patient was provided a back-up freedom ac power supply, and there was no reported adverse patient impact.
 
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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
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6112609
MDR Text Key60863201
Report Number3003761017-2016-00372
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
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 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295050-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age63 YR
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