Catalog Number 6252000000 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.71 devices were functionally/visually inspected in the field.These devices were repaired and returned to use.1 device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.2 devices are pending investigation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 73 malfunction events, where it was reported the unit was difficult to maneuver (no tip). there was no patient involvement.
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Manufacturer Narrative
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The final 2 devices were evaluated and the investigations were completed; the reported issues were confirmed.The devices were repaired and returned to use.
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Event Description
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This report summarizes 73 malfunction events, where it was reported the unit was difficult to maneuver (no tip). there was no patient involvement.
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Search Alerts/Recalls
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