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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL ENSITE X EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number ENSITE-DWS-01
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2023
Event Type  malfunction  
Event Description
During the pulmonary vein isolation procedure, it was reported that the system was slow and unable to map smoothly and there were several messages that appeared during system bootup.The computer was rebooted and switched to voxel mode, but the issue did not resolve.The procedure was abandoned with no adverse patient consequences, and subsequently completed later.The dws was replaced and the relevant software and modules were installed.
 
Manufacturer Narrative
Additional information: g3, h2, h3.Based on the information provided to abbott and the images submitted, the occurrence of the reported event can be confirmed.The image appear to show that there was a power on sequence symptom related to machine check errors (mce) related to the central processing unit (cpu or processor).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.
 
Manufacturer Narrative
Additional information: d9, g2, h2, h3, h6.One ensite x display workstation was received.Based on the returned images, the investigation, and information provided to abbott, the reported event was able to be confirmed, however the root cause was unable to be identified as the returned symptom was not reproduced.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.
 
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Brand Name
ENSITE X EP SYSTEM DISPLAY WORKSTATION
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key16570582
MDR Text Key311782051
Report Number2184149-2023-00063
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067032171
UDI-Public05415067032171
Combination Product (y/n)N
Reporter Country CodeAS
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 Physician
Type of Report Initial,Followup,Followup
Report Date 08/08/2023
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 Number7643525
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 02/20/2023
Initial Date FDA Received03/19/2023
Supplement Dates Manufacturer Received07/05/2023
07/18/2023
Supplement Dates FDA Received07/13/2023
08/08/2023
Was Device Evaluated by Manufacturer? Yes
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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