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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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ST. JUDE MEDICAL, INC. ENSITE PRECISION LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H702475
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Event Description
Prior to the procedure, there was sparking at the precision link power supply.The precision link power supply was damaged and sparked when it was plugged into the precision link.The locking collar on the power supply was noted to be missing.It was not missing at the previous case on (b)(6) 2021.
 
Manufacturer Narrative
One ensite¿ precision¿ link sensor enabled (pn 100133139 sn (b)(6)) was received for evaluation at tech center.Based on the information provided to abbott and the investigation performed, the root cause was isolated to a thermal event at the power connector.A review of the dhr was performed and ruled out the possibility of a manufacturing related issue causing or contributing to the reported complaint issue.
 
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Brand Name
ENSITE PRECISION LINK SENSOR ENABLED
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key11570158
MDR Text Key245925671
Report Number2184149-2021-00065
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05415067024756
UDI-Public05415067024756
Combination Product (y/n)N
PMA/PMN Number
K183128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberH702475
Device Catalogue NumberH702475
Device Lot Number5877244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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