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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X  EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. ENSITE X  EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number ENSITE-DWS-01
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
During the atrial fibrillation procedure, when the system was powered on, the luks password screen was displayed.The usb port and dvd drive were empty.The "enter" was pressed on the ensite with no resolution.The system was power cycled several times to resolve the issue.The procedure was completed without replacing the device and there were no adverse consequences to the patient.
 
Manufacturer Narrative
One ensite x display workstation (dws) was received for evaluation.The dws device accessories were connected along with power.Power was applied and the dws passed the power-on-self-test (post).The dws loaded the operating system successfully then ensite application main log-in screen loaded successfully with no errors.It was observed that the hostname installed was dwsx19005765.The main log-in information was not returned with the product.Hardware diagnostics revealed both the memory and the hard drive tests were successful.The reported event was not able to be duplicated.Hardware evaluation testing was successful.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the returned images, the investigation, and information provided to abbott, the reported event of power problem was confirmed, however the root cause remains undetermined.
 
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Brand Name
ENSITE X  EP SYSTEM DISPLAY WORKSTATION
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key14053222
MDR Text Key289201740
Report Number2184149-2022-00098
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067032171
UDI-Public05415067032171
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K202066
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2022
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 NumberENSITE-DWS-01
Device Catalogue NumberENSITE-DWS-01
Device Lot Number7986637
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2022
Initial Date FDA Received04/08/2022
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2021
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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