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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIT DEVICE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIT DEVICE Back to Search Results
Catalog Number 595000-001
Device Problem Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2014
Event Type  malfunction  
Event Description
The customer reported that the freedom driver exhibited chirping noises while supporting a pt.There was no reported adverse pt impact.The pt was subsequently switched to the backup freedom driver.Although the freedom driver exhibited noses, the driver continued to function as intended.This alleged failure mode posses a low risk to the pt because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
CIRCULATORY ASSIT DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq, vp
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4359957
MDR Text Key5238710
Report Number3003761017-2014-00292
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 Facility
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 11/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/26/2014
Date Device Manufactured12/01/2011
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 Age26 YR
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