Catalog Number 650700000000 |
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.3 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 3 malfunction events, where it was reported the devices experienced false engagement of handle in the upright or horizontal position or fowler cannot be lowered.There was no patient involvement.
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Manufacturer Narrative
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The 3 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.Section h codes have been updated to reflect this.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the devices experienced false engagement of handle in the upright or horizontal position or fowler cannot be lowered.There was no patient involvement.
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Search Alerts/Recalls
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