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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM ONBOARD BATTERY Back to Search Results
Catalog Number 295025-001
Device Problems Failure to Charge (1085); Charging Problem (2892)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient's two freedom onboard batteries were not maintaining a charge.The medical device report for freedom onboard battery s/n (b)(4) is #3003761017-2016-00159.The customer also reported that the patient was provided with replacement onboard batteries.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power.The freedom onboard batteries will be evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The freedom onboard battery was returned to syncardia for evaluation.Visual inspection revealed that freedom onboard battery s/n (b)(4) exhibited housing damage and therefore no further investigation could be performed.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).
 
Event Description
The customer reported that the patient's two freedom onboard batteries were not maintaining a charge.The medical device report for freedom onboard battery s/n (b)(4) is #3003761017-2016-00159.The customer also reported that the patient was provided with replacement onboard batteries.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM ONBOARD BATTERY
Type of Device
BATTERY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5626238
MDR Text Key44911336
Report Number3003761017-2016-00158
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/12/2016
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 Lay User/Patient
Device Catalogue Number295025-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2016
Initial Date FDA Received05/03/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2015
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 Age55 YR
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