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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE Back to Search Results
Catalog Number 595000-001
Device Problems False Alarm (1013); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2014
Event Type  malfunction  
Event Description
The customer reported that the freedom driver exhibited a fault alarm and strange noise 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 a fault alarm and noise, the driver continued to function as intended.This alleged failure mode poses 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 eval.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 ASSIST DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq., vp
1992 e. silverlake rd.
ce 2432
tucson, AZ 85713
5205451234
MDR Report Key4266410
MDR Text Key5227232
Report Number3003761017-2014-00244
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 10/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number595000-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2012
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 Age41 YR
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