Catalog Number 6252000000 |
Device Problem
Difficult or Delayed Positioning (1157)
|
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.64 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was functionally/visually inspected in the field; no defect or malfunction was found.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
|
|
Event Description
|
This report summarizes 66 malfunction events, where it was reported the devices experienced chair difficult to fold into seat position/fold up or difficult to maneuver.There was no patient involvement.
|
|
Event Description
|
This report summarizes 65 malfunction events, where it was reported the devices experienced chair difficult to fold into seat position/fold up or difficult to maneuver.There was no patient involvement.
|
|
Manufacturer Narrative
|
The device that was pending was evaluated and it was determined the device experienced chair leaning/tiled sideways (no tip), which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 66 to 65.
|
|
Search Alerts/Recalls
|