Catalog Number 650605550003 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 5 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.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.5 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 4 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There was no patient involvement.
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Manufacturer Narrative
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One of the records for this device was created in error for the wrong asset at the wrong account.This device did not have an alleged device malfunction.Because of this, the number of reported events has been changed from 5 to 4.
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Search Alerts/Recalls
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