Model Number 1460-000-000 |
Device Problem
Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Event Description
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This report summarizes 7 malfunction events, where it was reported the devices experienced armrest does not support weight or footrest does not support weight or seat section does not support weight.There was no patient involvement.
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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.6 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is 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 device that was pending was evaluated and it was determined the device experienced inoperable; loss of function foot rest, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 7 to 6.
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Event Description
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This report summarizes 6 malfunction events, where it was reported the devices experienced armrest does not support weight or footrest does not support weight or seat section does not support weight.There was no patient involvement.
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Search Alerts/Recalls
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