Catalog Number 6506000000 |
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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Event Description
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This report summarizes 17 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There were 2 events with patient involvement; no adverse consequences were reported.
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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.15 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Manufacturer Narrative
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The number of events has been updated to include an event previously reported on mfr report # 0001831750-2024-00659 following the completion of an investigation.2 devices are still pending evaluation.
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Event Description
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This report summarizes 18 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There were 2 events with patient involvement; no adverse consequences were reported.
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Search Alerts/Recalls
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