Model Number 6506 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
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.22 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.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 23 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler stuck elevated.There was no patient involvement.
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Manufacturer Narrative
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Method code was corrected one device.
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Event Description
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This report summarizes 23 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler stuck elevated.There was no patient involvement.
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Search Alerts/Recalls
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