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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2015
Event Type  malfunction  
Event Description
The customer reported that the patient reported that the freedom driver exhibited a fault alarm while watching television at home.The customer also reported that the freedom driver was plugged into ac power at the time of the fault alarm.The customer also reported that the patient switched to the backup driver without any adverse impact, and that he was asymptomatic during the event.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient reported that the freedom driver exhibited a fault alarm while watching television at home.The customer also reported that the freedom driver was plugged into ac power at the time of the fault alarm.The customer also reported that the patient switched to the backup driver without any adverse impact, and that he was asymptomatic during the event.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's exterior components revealed no abnormalities.Visual inspection of the driver's interior components revealed the secondary motor cam follower at top dead center (tdc) position, indicating that the driver had switched to operating on the secondary motor.The secondary motor is set to bottom dead center (bdc) position during driver manufacture/service.The driver passed all testing, including pressure test requirements associated with nominal normotensive and hypertensive settings, with no anomalies or alarms while connected to wall power.In addition, the secondary motor was tested to confirm proper operation of all electronics.The driver performed as intended, and there was no evidence of a device malfunction.The customer-reported fault alarm, in conjunction with the secondary motor found in tdc position is known to occur as a result of the driver experiencing an impact shock.The driver switched from the primary motor to the secondary motor, which resulted in the "secondary motor voltage too high" alarm.The motor/gearbox assemblies and pca were replaced as a precautionary measure.The driver was serviced and passed all final performance testing.The customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.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
FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ 85713
Manufacturer (Section G)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key4939793
MDR Text Key22560655
Report Number3003761017-2015-00235
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 consumer,health professional
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2015
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 Manufacturer07/15/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
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 Age65 YR
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