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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 Battery Problem (2885); Charging Problem (2892)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 07/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00259 and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00260).The customer reported that the patient reported that the freedom onboard battery would not charge beyond the second of five indicator lights.The customer also reported that the patient's onboard battery was exchanged.There was no reported patient impact.This alleged failure mode poses a low risk to the patient because although the freedom onboard battery has a low capacity, it did not prevent the freedom driver from performing its life-sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.The freedom onboard battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00259 and freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2016-00260).The customer reported that the patient reported that the freedom onboard battery would not charge beyond the second of five indicator lights.The customer also reported that the patient's onboard battery was exchanged.There was no reported patient impact.The onboard battery was returned to syncardia for evaluation.Visual inspection of the onboard battery revealed no abnormalities.The onboard battery was connected to battery evaluation software, and review of the smbus (system management bus) data revealed no permanent faults and no anomalous values.The displayed relative state of charge was consistent with the displayed fuel gauge leds.There was no indication that the onboard battery exhibited an incorrect gas gauge indication for the smbus displayed state of charge.The onboard battery was tested and passed all testing, which included gas gauge tests in fully charged, fully discharged and 70 percent states of charge.The onboard battery performed as intended, and there was no evidence of a malfunction.The onboard battery was returned to clinical use.The reported issue posed a low risk to the patient because it would not prevent the patient's freedom driver from performing its life-sustaining functions.In addition, patients are provided with several onboard batteries, and the freedom driver has a redundant power source of external wall power.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 Key5795176
MDR Text Key50518420
Report Number3003761017-2016-00260
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 07/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
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 Manufacturer08/05/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
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 Age49 YR
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