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 DRIVER; EXTERNAL PNEUMATIC DRIVER
  • 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 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
This freedom driver was not supporting a patient.The customer reported that both onboard batteries could be removed from the freedom driver at the same time, instead of one of the onboard batteries being locked in place when the other onboard battery was removed.This alleged failure mode poses a low risk to a patient because the freedom driver was not supporting a patient when the issue was observed.The freedom driver 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
This freedom driver was not supporting a patient.The customer reported that both onboard batteries could be removed from the freedom driver at the same time, instead of one of the onboard batteries being locked in place when the other onboard battery was removed.The freedom driver was returned to syncardia for evaluation.Visual inspection of the exterior and interior components of the driver revealed no abnormalities.The battery release latches and battery safety latches in the battery wells were inspected and no visual defects were found.During investigation testing, functional testing confirmed proper operation of the battery release latches and safety latches.The reported issue could only be reproduced by not fully inserting an onboard battery in a manner that allowed the onboard battery to make connection to power the driver and engage the battery safety latch without engaging the battery release latch.This method allowed the release of both onboard batteries.The investigation concluded that there was no evidence of a device malfunction and that the freedom driver performed as intended.The onboard batteries utilized by the customer at the time of the reported issue were not returned to syncardia and could not be evaluated as part of this investigation.It is possible that the onboard batteries could have been the cause of the reported issue.The freedom driver was serviced.The reported issue posed a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
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 Key5651108
MDR Text Key46260887
Report Number3003761017-2016-00201
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-