Catalog Number 4701000000 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
|
|
Event Description
|
This report summarizes 6 malfunction events, where it was reported the devices experienced foot section does not latch/lock (false latch) or false latch of siderail.There was no patient involvement.
|
|
Manufacturer Narrative
|
The 1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; the issue was confirmed.Section h codes have been updated.
|
|
Event Description
|
This report summarizes (b)(6) malfunction events, where it was reported the devices experienced foot section does not latch/lock (false latch) or false latch of siderail.There was no patient involvement.
|
|
Search Alerts/Recalls
|