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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems No Display/Image (1183); Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The companion 2 driver was not supporting a patient.The customer reported that they were unable to change the settings or interact with the hospital cart or companion 2 screen.The customer also reported that they were unable to calibrate the companion 2 driver because the cursor would not follow the touch screen.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the exterior components revealed no abnormalities.Review of the electronic patient data file revealed no unusual alarms.Calibration is performed when the companion 2 driver is docked in a companion hospital cart.When performing the touch screen calibration, two options are provided on the touch screen: driver screen calibration and hospital cart screen calibration.If hospital cart screen calibration is selected on the touch screen but the calibration is performed on the driver touch screen, it can affect the hospital cart's touch screen performance.If driver screen calibration is selected on the touch screen but the calibration is performed on the hospital cart touch screen, it can affect the driver's touch screen performance.It is possible that the calibration could have been performed on the touch screen that was different from the touch screen that was selected, resulting in inaccurate calibration data.The reported non-responsive touch screen was confirmed during incoming testing of the driver.The root cause was inaccurate calibration data on the micro sd card.The micro sd card is a secure digital flash memory card used for storing companion 2 driver system information.The calibration data is stored on the sd card and remains until the calibration procedure is reexecuted.In this case, the saved calibration data was inaccurate, and a new calibration could not be performed.The sd card was replaced, and the issue was resolved.The companion 2 driver was serviced and then passed all final performance testing.This failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.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 companion 2 driver was not supporting a patient.The customer reported that they were unable to change the settings or interact with the hospital cart or companion 2 screen.The customer also reported that they were unable to calibrate the companion 2 driver because the cursor would not follow the touch screen.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5839949
MDR Text Key52287739
Report Number3003761017-2016-00281
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
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
Type of Report Initial,Followup
Report Date 07/21/2016
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 Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2016
Initial Date FDA Received08/02/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2012
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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