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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 09/08/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The companion 2 driver was not in use by a patient.The customer reported that the text on gui monitor buttons on the companion 2 driver and companion hospital cart disappeared when the buttons were pushed on the screen.This alleged failure mode poses a low risk to the patient because it was not in patient use.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The companion 2 driver was not in use by a patient.The customer reported that the text on the graphical user interface (gui) monitor buttons on the companion 2 driver and companion hospital cart disappeared when the buttons were pushed on the screen.Companion 2 driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the interior and exterior of the driver revealed no anomalies.The customer reported issue of the missing gui text could not be duplicated.The gui text remained visible during the investigation and no anomalies were observed with the driver's touchscreen.The gui software for the user display is programmed into a micro secure digital (sd) card.The sd card was replaced, the driver was serviced and passed all final performance testing.Risk to the patient was low because the driver was not supporting a patient at the time of the customer reported issue.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.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5084308
MDR Text Key26490467
Report Number3003761017-2015-00292
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 09/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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