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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Event Description
Device failed incoming inspection testing.Multiple faults all pertain to emergency battery error.Failed system check for 9 volt battery.Moments after driver booted up emergency battery displayed alarm and ten tone burst alarm.
 
Event Description
Device failed incoming inspection testing.Multiple faults all pertain to emergency battery error.Failed system check for 9 volt battery.Moments after driver booted up emergency battery displayed alarm and ten tone burst alarm.
 
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Brand Name
SYNCARDIA COMPANION 2 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 Key18035298
MDR Text Key326961115
Report Number3003761017-2023-00144
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,User Facility,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 03/06/2024
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 Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/04/2023
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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