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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 Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
The freedom battery charger will be returned to syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported the freedom battery charger was not working properly and that it seemed as if 2 "wells" were not charging the batteries.There was no reported adverse impact to the patient.
 
Manufacturer Narrative
During investigation testing, the customer-reported issue of the battery charger not working properly was confirmed.The root cause was determined to be a malfunction of the charging port corresponding to bay 4 of the freedom battery charger's printed circuit board assembly (pcba) as it appeared to be physically damaged.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.(b)(4) 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 AZ 85713
MDR Report Key9548683
MDR Text Key174683142
Report Number3003761017-2020-00005
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 health professional,user faci
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295054-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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