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Device
decontamination systems for n95 respirators
Definition
Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Product Code
QKY
Device Class
Not Classified
MDR Year
MDR Reports
MDR Events
2020
202
202
2021
103
103
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
116
116
Contamination
41
41
Device Emits Odor
37
37
Break
33
33
Material Too Soft/Flexible
19
19
Insufficient Information
18
18
No Apparent Adverse Event
14
14
Fluid/Blood Leak
13
13
Stretched
11
11
Peeled/Delaminated
5
5
Device Reprocessing Problem
5
5
Degraded
4
4
Material Frayed
3
3
Leak/Splash
3
3
Defective Device
3
3
Material Deformation
3
3
Environmental Particulates
2
2
Material Discolored
2
2
Dent in Material
2
2
Fumes or Vapors
2
2
Tear, Rip or Hole in Device Packaging
1
1
Material Puncture/Hole
1
1
Problem with Sterilization
1
1
Material Opacification
1
1
Corroded
1
1
Unintended Electrical Shock
1
1
Moisture or Humidity Problem
1
1
Contamination /Decontamination Problem
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
147
147
Viral Infection
33
33
Cough
29
29
Burning Sensation
29
29
Skin Inflammation/ Irritation
25
25
Headache
24
24
Sore Throat
23
23
Nasal Obstruction
20
20
Dyspnea
19
19
Rash
15
15
Discomfort
9
9
Itching Sensation
9
9
Nausea
9
9
Skin Discoloration
9
9
Fatigue
9
9
Dizziness
7
7
Sneezing
6
6
Hypersensitivity/Allergic reaction
6
6
Fever
5
5
Diarrhea
5
5
No Patient Involvement
5
5
Chills
5
5
Eye Pain
4
4
Burn(s)
3
3
Confusion/ Disorientation
3
3
Chemical Exposure
3
3
Chest Pain
3
3
Insufficient Information
3
3
Swelling/ Edema
3
3
Skin Disorders
3
3
Ageusia
2
2
Asthma
2
2
Caustic/Chemical Burns
2
2
Unspecified Respiratory Problem
2
2
No Known Impact Or Consequence To Patient
1
1
Virus
1
1
Localized Skin Lesion
1
1
Eye Burn
1
1
Cellulitis
1
1
Skin Burning Sensation
1
1
Vomiting
1
1
Blister
1
1
Cognitive Changes
1
1
Numbness
1
1
Neck Pain
1
1
Erythema
1
1
Electric Shock
1
1
Epistaxis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Battelle Memorial Institute
II
Oct-29-2020
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