ST. JUDE MEDICAL, INC. AO USB RECEIVER; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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Model Number C12782 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturing ref: 2184149-2020-00241, 3009600098-2020-00029.During the procedure, a significant delay occurred.The start up of the system was significantly prolonged and "ffr receiver fault detect" was displayed after startup.The connection between the catheter and the doc failed and it took two to three times to connect successfully.After detection the imaging effect was not good, the brightness and contrast were not high, and the nature of the plaque could not be seen clearly.The procedure was completed with the same system with no adverse patient consequences.The ffr receivers and optical adapter were replaced to resolve the issue.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received and electronic data, the reported incident is verified to have occurred, but the cause could not be determined.
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Search Alerts/Recalls
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