Catalog Number UNKNOWN |
Device Problem
No Display/Image (1183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2018 |
Event Type
malfunction
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Event Description
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It was reported that during procedure, monitor blacked out.A backup device was available to complete the procedure with no delay or patient injuries reported.
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Event Description
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It was reported that during procedure, scope image blacked out.A backup device was available to complete the procedure with no delay or patient injuries reported.
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Manufacturer Narrative
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Brand name updated as unknown since device information was updated to report the scope and this information is not available yet.Product code updated.Catalog number updated as unknown since device information was updated to report the scope and this information is not available yet.Serial number updated as unknown.
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Manufacturer Narrative
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Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
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Manufacturer Narrative
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H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4) (s+n austin).The correct manufacturing site information and registration number is (b)(4) (s+n andover).Corrected data: d3 and g1 manufacturing site name, address and contact information.
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Search Alerts/Recalls
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