Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION POWER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
 
Event Description
Related manufacturer reference: 2184149-2019-00142.During preparation, a spark was noted when using the precision link power input.Some of the pins appeared to have fused together.There was no patient involved.
 
Event Description
The cable produced the spark when it was attached to the link.
 
Manufacturer Narrative
One ensite precision¿ power cable was received for evaluation.Visual inspection of the returned power cable revealed physical damage due to a detached collar housing on the redel which was held on by electrical tape and would have led to the field reported event of a spark.The cause of the damage is unknown. the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENSITE PRECISION POWER CABLE
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key8851351
MDR Text Key153380645
Report Number2184149-2019-00143
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K172396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100143451
Device Lot Number6410369
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Was the Report Sent to FDA? No
Date Manufacturer Received08/02/2019
Patient Sequence Number1
Treatment
ENSITE¿ PRECISION¿ LINK SENSOR ENABLED
-
-