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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, tubing and support, ventilator (w harness)
Product CodeBZO
Regulation Number 868.5975
Device Class 1

MDR Year MDR Reports MDR Events
2019 33 33
2020 30 30
2021 52 52
2022 66 66
2023 37 37
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 99 99
Break 49 49
Detachment of Device or Device Component 16 16
Gas/Air Leak 16 16
Mechanical Problem 12 12
Disconnection 11 11
Fracture 10 10
Leak/Splash 6 6
Material Puncture/Hole 5 5
Crack 4 4
Loose or Intermittent Connection 3 3
Defective Component 3 3
Fitting Problem 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Disintegration 2 2
Obstruction of Flow 2 2
Infusion or Flow Problem 2 2
Gas Output Problem 2 2
Device Handling Problem 2 2
Physical Resistance/Sticking 1 1
Device Fell 1 1
Suction Failure 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Pressure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Improper Chemical Reaction 1 1
Improper Flow or Infusion 1 1
Device Contamination with Chemical or Other Material 1 1
Material Fragmentation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 142 142
No Consequences Or Impact To Patient 23 23
No Patient Involvement 17 17
Low Oxygen Saturation 13 13
Insufficient Information 13 13
No Known Impact Or Consequence To Patient 11 11
Decreased Respiratory Rate 4 4
Pulmonary Insufficiency 2 2
Skin Erosion 1 1
Therapeutic Effects, Unexpected 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Hypoxia 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Chest Tightness/Pressure 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Cough 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Mallinckrodt Manufacturing LLC I Sep-09-2023
3 TELEFLEX MEDICAL INC II May-24-2022
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