Catalog Number 0620040610 |
Device Problem
Increase in Pressure (1491)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that overpressure occured.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: overpressure probable root cause: pressure sensor malfunction / out of calibration.Software malfunction.Use error.System design.Unwanted movement of internal components / wiring.Pressure button does not disengage.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.The device manufacture date is not known.
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Event Description
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It was reported that overpressure occured.
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Search Alerts/Recalls
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