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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 Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2014
Event Type  malfunction  
Event Description
The freedom driver was not supporting a pt.A syncardia clinical support specialist reported that the freedom driver did not pass the system check.He also reported that when he inserted a freedom onboard battery into the driver, the driver immediately exhibited a fault alarm.This alleged failure mode poses a low risk to a pt because the issue was observed when the freedom driver was not supporting a pt.The freedom driver will be returned to a 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 ASSIST 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 Key4436903
MDR Text Key5310063
Report Number3003761017-2015-00330
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2015
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 Received12/30/2014
Was Device Evaluated by Manufacturer? No
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
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