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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 Output Problem (3005); Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Event Description
Freedom driver (b)(6) came in with a beat rate of 181 bpm.Driver also started alarming when the driver was powered.Beat rate was lowered to 161 bpm.Testing was unable to be completed at this beat rate.
 
Event Description
Freedom driver #5025 came in with a beat rate of 181 bpm.Driver also started alarming when the driver was powered.Beat rate was lowered to 161 bpm.Testing was unable to be completed at this beat rate.
 
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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 Key18068013
MDR Text Key327319307
Report Number3003761017-2023-00151
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 Other,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/09/2023
Was Device Evaluated by Manufacturer? Yes
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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