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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION POWER CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. ENSITE PRECISION POWER CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 100143451
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
During set up for a procedure the ensite precision link power supply cable fell apart and sparked. A different power supply was utilized for the scheduled procedure. There were no user consequences.
 
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Brand NameENSITE PRECISION POWER CABLE
Type of DeviceCOMPUTER, 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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9531935
MDR Text Key191763507
Report Number2184149-2019-00258
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100143451
Device Catalogue NumberH702475
Device Lot Number6859138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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