Catalog Number FL19H |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
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.5 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device 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 8 malfunction events, where it was reported the devices experienced end/siderail cannot latch.There was no patient involvement.
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Manufacturer Narrative
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The 2 devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.
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Event Description
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This report summarizes 8 malfunction events, where it was reported the devices experienced end/siderail cannot latch.There was no patient involvement.
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Search Alerts/Recalls
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