Model Number 0279401200 |
Device Problem
Continuous Firing (1123)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device continuously activated.
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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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Event Description
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It was reported that the device continuously activated.
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Manufacturer Narrative
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Alleged failure: the probe remained partially active even though the user had removed the finger from the activation buttons.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a probe short due to a fluid ingress, an internal leak due to a broken/damaged bond of the polyimide, and suction tubing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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