Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY Back to Search Results
Catalog Number 295025-001
Device Problems Failure to Charge (1085); Charging Problem (2892)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2015
Event Type  malfunction  
Event Description
The customer reported that the freedom onboard battery did not hold a charge.The customer also reported that the freedom onboard battery charged when inserted into the freedom battery charger, but when the freedom onboard battery was removed, it did not hold the charge.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because it would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external power.In addition, pts are provided with several onboard batteries.The onboard battery will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.
 
Manufacturer Narrative
(b)(4).Follow-up report 1.
 
Event Description
The customer reported that the freedom onboard battery did not hold a charge.The customer also reported that the freedom onboard battery charged when inserted into the freedom battery charger, but when the freedom onboard battery was removed, it did not hold the charge.There was no reported adverse patient impact.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.The onboard battery successfully passed physical inspection requirements with no observed abnormalities.Review of the onboard battery's smbus (system management bus) data revealed a permanent fault flag with max lifetime battery cell and max lifetime pack voltages greater than the first level safety thresholds.These voltages that the battery experienced are likely the cause for its permanent fault state, resulting in the inability of the battery to charge.This 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.Because the battery was inoperable, freedom onboard battery s/n (b)(4) 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4841712
MDR Text Key20798600
Report Number3003761017-2015-00180
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 Facility,health professional,use
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/22/2015
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 Manufacturer05/28/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2015
Initial Date FDA Received05/29/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age38 YR
-
-