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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 Battery Problem (2885); Device Operates Differently Than Expected (2913)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because the battery was in the battery charger and not in use in the patient's freedom driver at the time of the customer-reported issue.Additionally, the freedom driver has multiple redundant power sources (e.G., external power via ac power supply and car charger) and patients are provided with several freedom onboard batteries.The freedom onboard battery has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The freedom onboard battery was not supporting a patient at the time of the reported issue.The customer, a syncardia certified hospital, reported that the freedom onboard battery showed 5 leds when the battery charge gauge button was depressed while it was in the charger but no leds when the button was depressed when the battery was out of the charger.
 
Manufacturer Narrative
The freedom onboard battery was returned to syncardia for evaluation.The system management (smbus) flag data panels were reviewed and revealed that the battery exhibited a permanent fault input flag due to cell under-voltage conditions.The root cause for the battery's disabled output could not be conclusively determined; however, analysis of the smbus recorded data indicated that the battery was likely subjected to a deep discharge cycle with a prolonged duration prior to being recharged.The internal cells' natural self-discharge continued to drain the cells to an unsafe level, triggering its internal safety circuitry and permanently disabled the battery's input/output functions.A permanently faulted battery will display the state of charge when the permanent fault occurred when its gas gauge button is pressed while installed in a freedom battery charger, but will display zero bars of charge when the gas gauge button is pressed outside of the charger.Freedom driver system operator manual, section 6.5.1 checking onboard battery charge instructs patients to determine the charge status of each onboard battery before it is installed into a driver.Syncardia has a corrective and preventive action to address this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
 
Event Description
The freedom onboard battery was not supporting a patient at the time of the reported issue.The customer, a syncardia certified hospital, reported that the freedom onboard battery showed 5 leds when the battery charge gauge button was depressed while it was in the charger but no leds when the button was depressed when the battery was out of the charger.
 
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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
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6672164
MDR Text Key78675664
Report Number3003761017-2017-00108
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/08/2017
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 Biomedical Engineer
Device Catalogue Number295025-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/08/2017
Initial Date FDA Received06/27/2017
Supplement Dates Manufacturer Received01/03/2018
Supplement Dates FDA Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
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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