Catalog Number 6252000000 |
Device Problem
Difficult or Delayed Positioning (1157)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.67 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 was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
|
|
Event Description
|
This report summarizes 73 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was 1 event with patient involvement; no adverse consequences were reported.
|
|
Manufacturer Narrative
|
Upon inspection of 1 of the devices it was determined the device experienced cosmetic damage, which is not reportable.The final 3 devices were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.
|
|
Event Description
|
This report summarizes 72 malfunction events, where it was reported the devices experienced difficulty maneuvering (no tip).There was 1 event with patient involvement; no adverse consequences were reported.
|
|
Search Alerts/Recalls
|