Catalog Number 2141000000 |
Device Problem
No Audible Alarm (1019)
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Patient Problems
Fall (1848); 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.3 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.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 3 malfunction events, where it was reported the devices experienced clinician not alerted/aware of possible patient fall condition.There was 1 event with patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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