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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; CIRCULATORY ASSIST DEVICE

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SYNCARDIA SYSTEMS, INC. SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; CIRCULATORY ASSIST DEVICE Back to Search Results
Model Number CSS CONSOLE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
This css console was not supporting a patient.The customer reported that the css console monitoring computer only showed half of the screen during system checkout.This alleged failure mode poses a low risk to a patient because the issue was observed when the css console was not supporting a patient.In addition, it would not prevent the css console from performing its life-sustaining functions.The computer is a monitoring device only and does not control css console functionality.A replacement laptop was sent and the laptop computer that was removed from the console will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE
Type of Device
CIRCULATORY ASSIST DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq, vp
1992 e. silverlake rd.
tucson, AZ 85713
5205451234
MDR Report Key4360290
MDR Text Key19315946
Report Number3003761017-2014-00297
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2014
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 Model NumberCSS CONSOLE
Device Catalogue Number400207
Device Lot Number29
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2014
Initial Date FDA Received12/15/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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