Catalog Number 0450000000I |
Device Problems
Image Display Error/Artifact (1304); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2023 |
Event Type
Injury
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Event Description
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It was reported that the procedure was cancelled and the patient potentially had incisions needing to be closed.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: e13 error message.Probable root cause: 1.Software.2.Main board failure.3.Front board failure.4.Imx module failure.5.Lcd touch panel failure.6.Esd onto touch screen.7.Bad touch screen calibration.8.Fluid ingress damages electrical components.9.Use error.10.Screen cracked.11.Console too sensitive to em emissions.12.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Event Description
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It was reported that the procedure was cancelled and the patient potentially had incisions needing to be closed.
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Search Alerts/Recalls
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