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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900); Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 08/28/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The freedom driver was not supporting a patient.The customer reported that there was difficulty in inserting a freedom on board battery into the right battery well.The customer also reported that the latch that holds the battery inside the freedom driver is locked and prevented the battery insertion.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.The freedom driver has a redundant, alternate power source of external wall power.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
(b)(4).
 
Event Description
The freedom driver was not supporting a patient.The customer reported that there was difficulty in inserting a freedom onboard battery into the right battery well.The customer also reported that the latch that holds the battery inside the freedom driver is locked and prevented the battery insertion.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components of the driver, which included inspection of the battery wells, revealed no damage or abnormalities.The onboard batteries used by the customer at the time of the reported issue were not returned to syncardia and were not evaluated as part of this investigation.During investigation testing, the freedom driver performed as intended.In addition, there were no issues with inserting or removing an onboard battery in the right battery well, and the battery safety latches functioned as intended.The reported issue was not reproduced, and there was no evidence of a device malfunction.The driver was serviced and then passed all final performance testing.The reported issue posed a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing its life-sustaining functions.The freedom driver has a redundant, alternate power source of external wall power.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.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5056980
MDR Text Key25786312
Report Number3003761017-2015-00278
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
Type of Report Initial,Followup
Report Date 08/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2015
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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