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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)
Regulation Description Ventilator tubing.
Product CodeBZO
Regulation Number 868.5975
Device Class 1

MDR Year MDR Reports MDR Events
2020 30 30
2021 52 52
2022 66 66
2023 37 37
2024 45 45
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 99 99
Break 70 70
Gas/Air Leak 24 24
Detachment of Device or Device Component 16 16
Fracture 13 13
Disconnection 9 9
Mechanical Problem 7 7
Leak/Splash 5 5
Crack 4 4
Material Puncture/Hole 4 4
Defective Component 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loose or Intermittent Connection 3 3
Fitting Problem 2 2
Failure to Deliver 2 2
Obstruction of Flow 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Gas Output Problem 2 2
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Suction Failure 1 1
Material Disintegration 1 1
Device Fell 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Stretched 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Material Deformation 1 1
Misassembly by Users 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Improper Chemical Reaction 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 190
Low Oxygen Saturation 16 16
Insufficient Information 13 13
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 6 6
Decreased Respiratory Rate 4 4
Pneumothorax 3 3
Cardiac Arrest 2 2
No Information 1 1
Skin Erosion 1 1
Fall 1 1
Laceration(s) 1 1
Cough 1 1
Hypoxia 1 1
Therapeutic Effects, Unexpected 1 1
Ventilator Dependent 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Draeger, Inc. I Apr-03-2025
3 Mallinckrodt Manufacturing LLC I Sep-09-2023
4 Percussionaire Corporation I Sep-27-2024
5 TELEFLEX MEDICAL INC II May-24-2022
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