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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
Model Number 595000-001
Device Problem Difficult to Insert (1316)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2017
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.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported difficulty inserting onboard batteries into the freedom driver battery well.The onboard batteries could be easily inserted into other freedom drivers.
 
Event Description
The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported difficulty inserting onboard batteries into the freedom driver battery well.The onboard batteries could be easily inserted into other freedom drivers.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The customer-reported inability of onboard battery insertion into the left battery well was confirmed during visual inspection of the driver due to an onboard battery contact found in the left battery well.After the customer-reported issue was confirmed, the contact was removed from the battery well so that functional testing could be performed.The driver passed all required functional testing requirements, which included normotensive and hypertensive settings.It is unknown how the battery contact became stuck in the driver prior to the initial inspection of the driver at the center.It is possible that this contact could have become stuck in the well at syncardia at the end of functional testing, but the source cannot be conclusively determined from this investigation.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.
 
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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
MDR Report Key7013900
MDR Text Key92846179
Report Number3003761017-2017-00204
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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