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 04/01/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 80 malfunction events, where it was reported the devices experienced difficult to maneuver unit which does not result in a tip.There was no patient involvement.
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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.76 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.2 devices are pending evaluation.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 79 malfunction events, where it was reported the devices experienced difficult to maneuver unit which does not result in a tip.There was no patient involvement.
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Manufacturer Narrative
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2 devices that were pending evaluation were not made available by the customer; the reported issue was not confirmed.1 device that was pending was evaluated and it was determined the device experienced tracks cannot be stowed into position or deployed or unlock mid transport, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 80 to 79.
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Search Alerts/Recalls
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