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Catalog Number 650705550001 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
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.59 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.5 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 65 malfunction events, where it was reported the devices experienced false engagement of handle in the upright or horizontal position, cot height cannot be adjusted or fowler cannot be lowered.There was 1 event with patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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