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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 Problems Premature Discharge of Battery (1057); Charging Problem (2892)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2015
Event Type  malfunction  
Manufacturer Narrative
The freedom onboard battery will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.
 
Event Description
The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: freedom onboard battery s/n (b)(4) (mfr report #3003761017-2015-00225).The customer reported that the pt said the freedom onboard battery had a low capacity.The customer also reported that the freedom onboard battery was exchanged for a new freedom onboard battery without any pt impact.
 
Manufacturer Narrative
Follow-up 1 (1 of 2) - sn (b)(4).
 
Event Description
The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00224) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00225).The customer reported that the patient said the freedom onboard battery had a low capacity.The customer also reported that the freedom onboard battery was exchanged for a new freedom onboard battery without any patient impact.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.The onboard battery s/n (b)(4) successfully passed visual inspections, and the battery was within the useful life period at the time of the customer-reported issue.During investigation evaluation, onboard battery s/n (b)(4) could not communicate with the smbus (system management bus) reader and, therefore, was determined to be inoperative.The smbus is the communication protocol used to communicate with the freedom onboard batteries.The root cause for onboard battery s/n (b)(4) being inoperative could not be determined without further destructive disassembly.The freedom onboard battery is designed as a disposable unit, and no further investigation was conducted.Risk to the patient was low because it would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power, and patients are provided with several onboard batteries.Additionally, the patient is provided with additional onboard batteries.Because onboard battery s/n (b)(4) was inoperative, the battery was taken out of service.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.
 
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Brand Name
SYNCARDIA FREEDOM ONBOARD BATTERY
Type of Device
BATTERY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key4935628
MDR Text Key22409968
Report Number3003761017-2015-00224
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Followup
Report Date 07/06/2015
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 Manufacturer07/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
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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