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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 Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2014
Event Type  malfunction  
Event Description
This freedom driver was not supporting a pt.The customer reported that while performing a system check, it was difficult to insert the onboard batteries into the driver's battery wells.This alleged failure mode poses a low risk to a pt because the issue was observed during a routine system check when the driver was no supporting a pt.In addition, it would not prevent the freedom driver from performing its life-sustaining functions because the freedom driver has a redundant source of power and can be connected to external wall power.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 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 Key4214121
MDR Text Key5000280
Report Number3003761017-2014-00114
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2014
Initial Date FDA Received08/06/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2013
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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