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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 Problem Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a strange noise, it 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.(b)(4).
 
Event Description
The customer reported that the freedom driver made a strange noise.The customer also reported that the patient was subsequently switched to a backup freedom driver.There was no reported patient impact.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all required functional testing requirements, which included testing at nominal normotensive and hypertensive settings, with no anomalies or alarms.In addition, the driver was subjected to an additional 48 hour observation run and was confirmed to perform as intended with no issues.No unusual noises were confirmed, the root cause of the reported issue couldn't be determined.The driver performed as intended, and there was 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).
 
Event Description
The customer reported that the freedom driver made a strange noise.The customer also reported that the patient was subsequently switched to a backup freedom driver.There was no reported 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
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5999781
MDR Text Key57185905
Report Number3003761017-2016-00334
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2016
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 Manufacturer10/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2015
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 Age56 YR
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