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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeQKY
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
Burning Sensation 29 29
Cough 29 29
Skin Inflammation/ Irritation 25 25
Headache 24 24
Sore Throat 23 23
Nasal Obstruction 20 20
Dyspnea 19 19
Rash 15 15
Skin Discoloration 9 9
Itching Sensation 9 9
Nausea 9 9
Fatigue 9 9
Discomfort 9 9
Dizziness 7 7
Sneezing 6 6
Hypersensitivity/Allergic reaction 6 6
Fever 5 5
Diarrhea 5 5
Chills 5 5
No Patient Involvement 5 5
Eye Pain 4 4
Swelling/ Edema 3 3
Insufficient Information 3 3
Skin Disorders 3 3
Chemical Exposure 3 3
Confusion/ Disorientation 3 3
Burn(s) 3 3
Chest Pain 3 3
Asthma 2 2
Caustic/Chemical Burns 2 2
Ageusia 2 2
Unspecified Respiratory Problem 2 2
Blister 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
No Known Impact Or Consequence To Patient 1 1
Epistaxis 1 1
Cognitive Changes 1 1
Eye Burn 1 1
Electric Shock 1 1
Numbness 1 1
Neck Pain 1 1
Cellulitis 1 1
Erythema 1 1
Virus 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Battelle Memorial Institute II Oct-29-2020
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