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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 Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2017
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.
 
Event Description
The freedom driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the freedom driver battery well latch did not lock in place a freedom onboard battery.The onboard battery could be easily pulled out of the well without depressing the release button.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The customer-reported experience of the driver running while the onboard batteries were not fully inserted was reproduced during investigation testing.The electrical contacts are at the bottom of the battery and when inserted into the battery well it is possible for the electrical contacts to make a connection before the mechanical latch is engaged.When an onboard battery is not properly inserted, the safety battery latch does not engage and is not able to lock the battery in place.The driver passed all functional test requirements which also included verification of the battery locking mechanism; there was no evidence of a device malfunction.The freedom driver system operator manual (f-900013, section 6.5.2 and 6.5.3) explains that users should push down on onboard batteries to confirm that they are locked into place in the driver.The manual also explains how the locking mechanism of the freedom driver works, as follows: inserting the onboard batteries.The onboard batteries are designed to be inserted correctly into the driver in only one direction.Push down on the onboard battery until the battery is locked in place.Confirm that the onboard battery is locked in place by trying to remove it without pressing the battery release button.The freedom driver has a mechanism that locks one onboard battery into the driver at all times.This mechanism prevents the user from accidentally removing both onboard batteries at the same time.When one onboard battery is removed, the internal mechanism will lock the other onboard battery in place, making it impossible for two onboard batteries (that have been fully inserted properly) to be removed at the same time.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 authorized distributor, reported that the freedom driver battery well latch did not lock in place a freedom onboard battery.The onboard battery could be easily pulled out of the well without depressing the release button.The customer also reported that the freedom driver started even though the onboard battery was not latched into place.
 
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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 Key6815430
MDR Text Key83632158
Report Number3003761017-2017-00147
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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