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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
Model Number 397002-001
Device Problems Calibration Error (1078); No Display/Image (1183)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
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 has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the touchscreen on the companion 2 driver would not calibrate after repeated attempts.The customer also reported that companion 2 driver was docked in companion hospital cart (mfr.3003761017-2018-00015) when the cart touchscreen would not calibrate.
 
Event Description
The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the touchscreen on the companion 2 driver would not calibrate after repeated attempts.The customer also reported that companion 2 driver was docked in companion hospital cart (mfr.3003761017-2018-00015) when the touchscreen would not calibrate.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue occurred while the companion 2 driver was docked in a companion hospital cart.Under separate investigation, the hospital cart was found to have a lcd display malfunction which would prohibit the accurate calibration of a driver touchscreen.The driver was installed into a known functional test hospital cart and the offset on the driver touch screen was corrected by selecting "driver calibration" on the hospital cart touch screen and completing the calibration on the driver touch screen.After calibration, driver touch screen functionality was restored.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.
 
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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
MDR Report Key7190000
MDR Text Key97951798
Report Number3003761017-2018-00016
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number397002-001
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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