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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Break (1069); Mechanical Problem (1384); Failure to Disconnect (2541); Mechanical Jam (2983); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 09/01/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The freedom driver was not supporting a patient.The customer reported that the patient kept pressing the battery release button on the freedom driver and he could not get the battery out of the driver.The syncardia clinical support specialist reported that the freedom onboard battery is jammed in the driver and she was able to get the battery out after a great deal of effort.The syncardia clinical support specialist also reported that there is a loose piece in the freedom driver that can be heard when the device is tilted from side to side.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.
 
Manufacturer Narrative
(b)(4) follow-up report 1.
 
Event Description
The freedom driver was not supporting a patient.The customer reported that the patient kept pressing the battery release button on the freedom driver and he could not get the battery out of the driver.The syncardia clinical support specialist reported that the freedom onboard battery is jammed in the driver and she was able to get the battery out after a great deal of effort.The syncardia clinical support specialist also reported that there is a loose piece in the freedom driver that can be heard when the device is tilted from side to side.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed damage to the left battery button and to the front housing above the left battery well, and a fracture on the front housing under the left battery button.The cause of the external damage is unknown.Visual inspection of the driver's internal components revealed a broken battery safety latch.This is what caused the difficulty in removing the onboard battery from the driver.The cause of the broken battery safety latch is unknown but can result from excessive force when trying to remove or insert an onboard battery.During investigation testing, the driver in "as received" condition passed all test requirements with no anomalies or alarms.Despite the broken battery safety latch, the driver continued to perform its life- sustaining functions.The driver was serviced, which included the replacement of the front housing and rear housing, battery button and the battery safety latch, before being placed into finished goods.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.
 
Manufacturer Narrative
(b)(4).Please note that this is a corrected report.Patient information has been changed to include the patient information.While the freedom driver was not supporting a patient, the device was assigned to the patient.
 
Event Description
The freedom driver was not supporting a patient.The customer reported that the patient kept pressing the battery release button on the freedom driver and he could not get the battery out of the driver.The syncardia clinical support specialist reported that the freedom onboard battery is jammed in the driver and she was able to get the battery out after a great deal of effort.The syncardia clinical support specialist also reported that there is a loose piece in the freedom driver that can be heard when the device is tilted from side to side.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed damage to the left battery button and to the front housing above the left battery well, and a fracture on the front housing under the left battery button.The cause of the external damage is unknown.Visual inspection of the driver's internal components revealed a broken battery safety latch.This is what caused the difficulty in removing the onboard battery from the driver.The cause of the broken battery safety latch is unknown but can result from excessive force when trying to remove or insert an onboard battery.During investigation testing, the driver in "as received" condition passed all test requirements with no anomalies or alarms.Despite the broken battery safety latch, the driver continued to perform its life- sustaining functions.The driver was serviced, which included the replacement of the front housing and rear housing, battery button and the battery safety latch, before being placed into finished goods.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
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5108692
MDR Text Key27106006
Report Number3003761017-2015-00302
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 Followup,Followup
Report Date 09/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2015
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 Manufacturer09/14/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age58 YR
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