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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
Catalog Number 595000-001
Device Problems Low Readings (2460); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver displayed a lower cardiac output (co).The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver displayed a lower cardiac output, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation the driver passed all functional test requirements with no anomalies or alarms.Additionally, an extended observation run was performed on the primary motor circuit and the driver functioned as intended with no evidence of a device malfunction.The customer reported low cardiac output could not be reproduced during investigation testing; therefore, a root cause for the reported issue could not be determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The customer reported that the freedom driver displayed a lower cardiac output (co).The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
 
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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 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5579970
MDR Text Key43553384
Report Number3003761017-2016-00140
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2015
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 Age69 YR
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