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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM BATTERY CHARGER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM BATTERY CHARGER Back to Search Results
Catalog Number 295054-001
Device Problem Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2019
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the freedom battery charger does not support patients.The freedom battery charger is being evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
While performing a routine evaluation, a syncardia technician reported that a battery well on the freedom battery charger was not working.
 
Manufacturer Narrative
During investigation testing, the reported issue with bay 1 of the battery charger was confirmed and reproduced.The root cause was determined to be a malfunction of a misconnected or damaged transient voltage suppressor element within the internal circuitry for bay 1 on the battery charger's printed circuit board assembly (pcba).This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 5023 follow-up report 1.
 
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Brand Name
SYNCARDIA FREEDOM BATTERY CHARGER
Type of Device
BATTERY CHARGER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key9298523
MDR Text Key165983182
Report Number3003761017-2019-00322
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/27/2019
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 Other
Device Catalogue Number295054-001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/23/2019
Initial Date FDA Received11/08/2019
Supplement Dates Manufacturer Received10/23/2019
Supplement Dates FDA Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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