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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 595000-001
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
The freedom driver will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.
 
Manufacturer Narrative
During investigation testing, the reported high left arterial pressure (lap) values were reproduced.The root cause was determined to be a malfunction of the piston cylinder assembly (pca).Syncardia has a corrective and preventive action (capa) to investigate this issue.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 5345 follow-up report 1.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson, az
MDR Report Key10477293
MDR Text Key205496312
Report Number3003761017-2020-00181
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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