Catalog Number 6252000000 |
Device Problem
Device Fell (4014)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/01/2023 |
Event Type
malfunction
|
Event Description
|
This report summarizes 5 malfunction events, where it was reported the devices experienced unexpected drop/collapse.There was 1 event with patient involvement; no adverse consequences were reported.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 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.
|
|
Search Alerts/Recalls
|