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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 Difficult to Remove (1528); Sticking (1597)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2016
Event Type  malfunction  
Manufacturer Narrative
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 power source of external power.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer reported that during a training/demonstration, the freedom onboard battery became stuck in the battery well of the freedom driver.The customer also reported that she was unable to remove the onboard battery after confirming that the dummy onboard battery was in place.She continued to try to remove the onboard battery but was unsuccessful after multiple attempts.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed damaged housing.Visual inspection of the internal components of the driver revealed a broken battery safety latch in the right battery well.This is the likely cause of the onboard battery extraction customer-reported issue.With a broken battery safety latch in the right well, an onboard battery in the left well would not be able to be removed.It cannot be conclusively determined how the battery safety latch in the right battery well became damaged, although the damage noted on the driver housing indicates rough handling (improper use), which is the most likely root cause of the customer-reported issue.The onboard battery returned with the driver passed a fit check when performed with a clinical driver and met all dimensional tolerances on the released version of the drawing.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 during a training/demonstration, the freedom onboard battery became stuck in the battery well of the freedom driver.The customer also reported that she was unable to remove the onboard battery after confirming that the dummy onboard battery was in place.She continued to try to remove the onboard battery but was unsuccessful after multiple attempts.
 
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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 Key5993570
MDR Text Key56813282
Report Number3003761017-2016-00330
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 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2016
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 Manufacturer10/03/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2012
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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