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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
2021 52 52
2022 66 66
2023 37 38
2024 45 45
2025 71 71
2026 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 122 122
Break 97 97
Obstruction of Flow 62 62
Gas/Air Leak 43 43
Physical Resistance/Sticking 17 17
Detachment of Device or Device Component 16 16
Fracture 13 13
Disconnection 7 7
Leak/Splash 4 4
Mechanical Problem 4 4
Fluid/Blood Leak 4 4
Crack 3 4
Material Puncture/Hole 3 3
Defective Component 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Fitting Problem 2 2
Gas Output Problem 2 2
Failure to Deliver 2 2
Failure of Device to Self-Test 2 2
Inadequacy of Device Shape and/or Size 2 2
No Flow 1 1
Loose or Intermittent Connection 1 1
Improper Chemical Reaction 1 2
Material Too Soft/Flexible 1 1
Connection Problem 1 1
Protective Measures Problem 1 1
Failure to Calibrate 1 1
Increase in Pressure 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 1 1
Device Handling Problem 1 1
Misassembly by Users 1 1
Material Deformation 1 1
Insufficient Flow or Under Infusion 1 1
Improper Flow or Infusion 1 1
Use of Device Problem 1 1
Stretched 1 1
Material Fragmentation 1 2
Patient Device Interaction Problem 1 1
Contamination /Decontamination Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Tidal Volume Fluctuations 1 1
Device Fell 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 311 312
Low Oxygen Saturation 23 23
Insufficient Information 14 14
Decreased Respiratory Rate 4 4
Pneumothorax 3 3
Abrasion 2 2
Cardiac Arrest 2 2
Airway Obstruction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoventilation 1 1
Skin Erosion 1 1
Fall 1 1
Laceration(s) 1 1
Cough 1 1
Hypoxia 1 1
Therapeutic Effects, Unexpected 1 1
Respiratory Insufficiency 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 Hamilton Medical AG I Jul-30-2025
4 Mallinckrodt Manufacturing LLC I Sep-09-2023
5 Percussionaire Corporation I Oct-14-2025
6 Percussionaire Corporation I Sep-27-2024
7 TELEFLEX MEDICAL INC II May-24-2022
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