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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY Back to Search Results
Catalog Number 295025-001
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2014
Event Type  malfunction  
Event Description
This onboard battery was not in use in a patient's freedom driver.The customer reported that when the freedom onboard battery was placed into the freedom battery charger, the freedom onboard battery would not display a light indicating that the freedom onboard battery was charging.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom onboard battery was not in patient use.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.See scanned page.
 
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Brand Name
SYNCARDIA FREEDOM ONBOARD BATTERY
Type of Device
BATTERY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq., v.p.
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4445103
MDR Text Key20772687
Report Number3003761017-2014-00316
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
Report Date 12/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295025-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received12/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2014
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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