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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 400207
Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2017
Event Type  malfunction  
Manufacturer Narrative
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 has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the patient was being supported by the upper controller of the css console.The customer also reported that while preparing the css console lower controller for backup purposes, it could not reach the desired pressure levels before the turning knob limit was reached.There was no reported adverse patient impact.
 
Manufacturer Narrative
The css console was returned to syncardia for evaluation.The customer-reported issue was confirmed during investigation testing.The root cause was determined to be a malfunction of the pressure gauge.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).
 
Event Description
The customer, a syncardia certified hospital, reported that the patient was being supported by the upper controller of the css console.The customer also reported that while preparing the css console lower controller for backup purposes, it could not reach the desired pressure levels before the turning knob limit was reached.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA CIRCULATORY SUPPORT SYSTEM 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 Key6263491
MDR Text Key65607319
Report Number3003761017-2017-00014
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 Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number400207
Device Lot Number25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2015
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 Age55 YR
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