Model Number 3005 |
Device Problem
Device Fell (4014)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
|
|
Event Description
|
This report summarizes 1 malfunction event, where it was reported the device experienced fowler unexpected drop/collapse.There was no patient involvement.
|
|
Event Description
|
This report summarizes 1 malfunction event, where it was reported the device experienced fowler unexpected drop/collapse.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; no defect or malfunction was found.
|
|
Search Alerts/Recalls
|