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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 Problems Material Separation (1562); 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
Additional information: d4, d9, g3, h2, h3, h6.One ensite precision¿ power cable (pn 100143451 sn k16230154) was received for evaluation at tech center.The field reported event was confirmed.Based on the information provided to abbott and the investigation performed, the root cause was isolated to a thermal event at the electrical pins at the redel connector end.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 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 Key11570130
MDR Text Key245767640
Report Number2184149-2021-00066
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
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 Number100143451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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