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 Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to a patient because the issue was observed while the freedom driver was not supporting a patient.The torx-head screw will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The customer, a syncardia authorized distributor, reported that the torx-head screw that secures the beat rate cover onto the freedom driver was the wrong size and could not be removed with the proper syncardia provided tool.
 
Manufacturer Narrative
The torx-head screw was returned to syncardia for evaluation.A device history record review found no anomalies in the manufacturing of the freedom driver from which the screw came.Comparison of the returned torx screw to a standard torx screw selected at random from the factory stock used to assemble freedom drivers revealed no differences.Both screws had the same head size, (¼ inch), width (0.11 inch), and number of threads (40 threads per inch).Both screws fit on both a shop tool and a sample tool of the type included in customer kits and both screws fit the potentiometer cover of several freedom drivers without any issues.Based on all available evidence, the correct screw was used during manufacturing and there is no 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, a syncardia authorized distributor, reported that the torx-head screw that secures the beat rate cover onto the freedom driver was the wrong size and could not be removed with the proper syncardia provided tool.
 
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
MDR Report Key7267968
MDR Text Key100261397
Report Number3003761017-2018-00053
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-