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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 Problems Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Manufacturer Narrative
The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
 
Event Description
The customer, a syncardia authorized distributor, reported that the freedom driver exhibited multiple fault alarms in a few hours while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
 
Event Description
The customer, a syncardia authorized distributor, reported that the freedom driver exhibited multiple fault alarms in a few hours while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
 
Manufacturer Narrative
Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two new alarms indicating left driver pressure too low for long enough resulting in permanent time-out and secondary motor voltage too high.Investigation determined secondary motor voltage alarm occurred during data extraction and permanent time-out occurs when driver runs while disconnected from patient.Visual inspection of external components found damage to driver housing front near left battery well, display cover and window, power adapter attaching slide, driver housing rear under exhaust cover on left side, and exhaust cover.Visual inspection of internal components found the ribbon cable speaker to lcd has a melt mark near the primary motor.Freedom driver passed all areas of functional testing for acceptance at incoming inspection.An extended observation run was performed.No alarms or issues were produced.Additionally, primary and secondary motors were able to be spun freely by hand.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated during testing; the root cause of the fault alarms was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Internal and external damage was cosmetic only.No evidence of a device malfunction was found.Patient was switched to a backup driver without any reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
 
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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 (Section G)
SYNCARDIA SYSTEMS, LLC
1992 e silverlake road
tucson AZ 85713
Manufacturer Contact
aaron meier
1992 e silverlake road
tucson, AZ 85713
5205451234
MDR Report Key14102977
MDR Text Key289252994
Report Number3003761017-2022-00040
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 Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
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 Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2019
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 Age29 YR
Patient SexMale
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