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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 103 103
Break 50 50
Detachment of Device or Device Component 17 17
Gas/Air Leak 17 17
Mechanical Problem 12 12
Disconnection 11 11
Fracture 11 11
Leak/Splash 6 6
Material Puncture/Hole 5 5
Crack 4 4
Loose or Intermittent Connection 3 3
Defective Component 3 3
Gas Output Problem 2 2
Connection Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Separation 2 2
Device Handling Problem 2 2
Infusion or Flow Problem 2 2
Obstruction of Flow 2 2
Failure to Deliver 2 2
Material Disintegration 2 2
Fitting Problem 2 2
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
No Pressure 1 1
Use of Device Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper Flow or Infusion 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Misassembly by Users 1 1
Defective Device 1 1
Device Fell 1 1
Tear, Rip or Hole in Device Packaging 1 1
Suction Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Device Damaged Prior to Use 1 1
Physical Resistance/Sticking 1 1
Improper Chemical Reaction 1 1
Device Slipped 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
No Consequences Or Impact To Patient 23 23
No Patient Involvement 17 17
Insufficient Information 13 13
Low Oxygen Saturation 13 13
No Known Impact Or Consequence To Patient 11 11
Decreased Respiratory Rate 4 4
Pulmonary Insufficiency 2 2
Patient Problem/Medical Problem 1 1
No Information 1 1
Chest Tightness/Pressure 1 1
Cardiac Arrest 1 1
Skin Erosion 1 1
Bradycardia 1 1
Cough 1 1
Hypoxia 1 1
Therapeutic Effects, Unexpected 1 1
Sore Throat 1 1
Ventilator Dependent 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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