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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 Problem Device Displays Incorrect Message (2591)
Patient Problems High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.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) initial.
 
Event Description
The customer, a syncardia certified hospital, reported that the patient switched onto his backup freedom driver and after a few minutes the driver exhibited a fault alarm.The customer also reported that the patient was transported to the hospital and subsequently switched to a companion 2 driver.The customer also reported that the patient was hypertensive at first and then quieted down.There was no reported permanent patient impact.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed that the secondary motor cam follower was out of the bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed two new alarms: 2d (secondary motor voltage too high) and 2f (system current too high).The first alarm was likely recorded during the service process prior to shipment to the customer.The second alarm was likely recorded during patient support as a result of secondary motor engagement, which correlates to the findings during the visual inspection.During investigation testing, both the primary and secondary motor circuits of the driver were tested and functioned as intended.Additionally, the onboard batteries used during the customer-reported issue were tested and functioned as intended with no anomalies.The root cause of the secondary motor engaging (which caused the driver alarm) could not be determined, but may have been caused by impact shock as a result of rough handling or a near drop (jolt) during use as a backup driver.The device history record indicated that the driver was used as a backup driver for 49 days prior patient support.The freedom 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 customer, a syncardia certified hospital, reported that the patient switched onto his backup freedom driver and after a few minutes the driver exhibited a fault alarm.The customer also reported that the patient was transported to the hospital and subsequently switched to a companion 2 driver.The customer also reported that the patient was hypertensive at first and then quieted down.There was no reported permanent 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
MDR Report Key7038732
MDR Text Key93449764
Report Number3003761017-2017-00213
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
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 Manufacturer11/08/2017
Was the Report Sent to FDA? No
Date Manufacturer Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
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