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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VANTAGEVIEW SYSTEM; DISPLAY, CATHODE-RAY TUBE, MEDICAL
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ST. JUDE MEDICAL, INC. VANTAGEVIEW SYSTEM; DISPLAY, CATHODE-RAY TUBE, MEDICAL Back to Search Results
Model Number VS100003
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Event Description
During the procedure with the patient was on the table and intubated, the system lost all video after approximately 20-30 seconds.Troubleshooting did not resolve the issue and the procedure was cancelled with no consequences to the patient.
 
Manufacturer Narrative
Additional information: g3, h2, h3, h4.The product was not returned however, a replacement "monitor" was sent, but is unknown if it resolved the issue.The device history record was reviewed and found to be complete.Based on the information received, the cause of the reported display issue and subsequent cancellation remains unknown.If the issue persists it is recommended to return the product for evaluation.
 
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Brand Name
VANTAGEVIEW SYSTEM
Type of Device
DISPLAY, CATHODE-RAY TUBE, MEDICAL
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key11965832
MDR Text Key255103525
Report Number2184149-2021-00194
Device Sequence Number1
Product Code DXJ
UDI-Device Identifier05415067010841
UDI-Public05415067010841
Combination Product (y/n)N
PMA/PMN Number
K110085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVS100003
Device Catalogue NumberVS100003
Device Lot Number6258246
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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