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 CSS CONSOLE; 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 CSS CONSOLE; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 400207
Device Problem Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that there was a loud humming noise coming from the css console while it was supporting a patient.The customer also reported that the patient was switched to a backup driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the css console from performing its life-sustaining functions.The css console will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The css console was returned to syncardia for evaluation.During investigation testing, the customer-reported humming noise was verified.The root cause was determined to be a malfunction of the power supply.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 there was a loud humming noise coming from the css console while it was supporting a patient.The customer also reported that the patient was switched to a backup driver.There was no reported adverse patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CSS CONSOLE
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 Key5943122
MDR Text Key54839065
Report Number3003761017-2016-00318
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 Biomedical Engineer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/02/2016
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 Health Professional
Device Catalogue Number400207
Device Lot Number12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/02/2016
Initial Date FDA Received09/12/2016
Supplement Dates Manufacturer Received12/05/2017
Supplement Dates FDA Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2015
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 Age62 YR
-
-