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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 Problems Device Inoperable (1663); Noise, Audible (3273)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Date 09/12/2017
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 that the freedom driver exhibited an unusual noise during the freedom driver check in process.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The customer-reported experience of squeaking and rattling could not be confirmed or reproduced during investigation testing.External and internal visual inspection of the driver revealed no abnormalities, and the driver passed all functional testing.An additional 48 hour extended observation run was performed and the driver performed as intended with no evidence of a device malfunction.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 freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited an unusual noise during the freedom driver check in process.
 
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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 Key6884702
MDR Text Key87856646
Report Number3003761017-2017-00182
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 Health Professional
Type of Report Initial,Followup
Report Date 09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
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 Manufacturer09/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2017
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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