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, LLC 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, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 595000-001
Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient switched from his primary freedom driver to his backup freedom driver because his primary freedom driver was overheating and exhibited a temperature alarm.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver was overheating and exhibited a temperature alarm, it continued to perform its life-sustaining functions.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
The freedom driver was returned to syncardia for evaluation.The reported issue of the driver overheating could not be reproduced or confirmed.The driver met all test acceptance criteria.Additionally, the driver functioned as intended through a 48-hour extended observation run and did not overheat or alarm.There was no evidence of a device malfunction.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.(b)(4) follow-up report 1.
 
Event Description
The customer reported that the patient switched from his primary freedom driver to his backup freedom driver because his primary freedom driver was overheating and exhibited a temperature alarm.There was no reported adverse patient impact.
 
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, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5651089
MDR Text Key46264932
Report Number3003761017-2016-00202
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 05/09/2016
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 Lay User/Patient
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age51 YR
-
-