|
Device Problems
Material Deformation (2976); No Apparent Adverse Event (3189)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/27/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device not returned.Since the time of issue, no other concerns or complaints regarding the masks have been reported by hospital staff.
|
|
Event Description
|
User reported mask not maintaining its shape.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.
|
|
Search Alerts/Recalls
|
|
|