ST. JUDE MEDICAL, INC. ENSITE PRECISION LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number H702475 |
Device Problem
Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2021 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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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