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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 Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2023
Event Type  malfunction  
Event Description
Patient's beat rate was adjusted on their primary freedom driver.While adjusting the rate on the 2 back-up drivers, freedom driver 5225a (with power adapter 1081) got an onboard battery s/n (b)(6) got stuck in it.After many "ferocious attempts", they were unable to remove the battery.
 
Event Description
Patient's beat rate was adjusted on their primary freedom driver.While adjusting the rate on the 2 back-up drivers, freedom driver 5225a (with power adapter 1081) got an onboard battery s/n (b)(6) got stuck in it.After many "ferocious attempts", they were unable to remove the battery.
 
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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 Key18035600
MDR Text Key326939805
Report Number3003761017-2023-00146
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 Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2023
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
Patient Age48 YR
Patient SexMale
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